{"id":26,"date":"2025-01-08T12:20:50","date_gmt":"2025-01-08T12:20:50","guid":{"rendered":"https:\/\/www.rqmplus.com\/?page_id=26"},"modified":"2025-09-19T13:06:55","modified_gmt":"2025-09-19T18:06:55","slug":"combination-products","status":"publish","type":"page","link":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/","title":{"rendered":"Combination Products"},"content":{"rendered":"<div id=\"rqm-divider-block_26d18710a6dbfda7a4883836886a9e13\" class=\"block-rqm-divider rqm-dots-animate\" style=\"\">\n    <div class=\"rqm-divider\">\n        <div class=\"rqm-dots-divider\" style=\"display:flex;gap:19px;width:427px;\">\n    <svg class=\"rqm-dots\" viewBox=\"0 0 503.26 131.31\" aria-hidden=\"true\" height=\"40\" width=\"153\" style=\"display:block;\">\n        <g class=\"dots-start\" fill=\"#ffce06\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"251.63\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"437.61\" cy=\"65.65\" r=\"65.65\"\/>\n        <\/g>\n    <\/svg>\n    <svg class=\"rqm-dots-grad\" viewBox=\"0 0 823.14 131.31\" aria-hidden=\"true\" height=\"40\" width=\"255\" style=\"display:block; border-radius: 50px;\" preserveAspectRatio=\"xMaxYMid slice\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\" fill=\"#ffce06\"\/>\n            <circle cx=\"71.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ffcb08\"\/>\n            <circle cx=\"77.15\" cy=\"65.65\" r=\"65.65\" fill=\"#fec80b\"\/>\n            <circle cx=\"82.89\" cy=\"65.65\" r=\"65.65\" fill=\"#fec50d\"\/>\n            <circle cx=\"88.64\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc20f\"\/>\n            <circle cx=\"94.39\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc011\"\/>\n            <circle cx=\"100.13\" cy=\"65.65\" r=\"65.65\" fill=\"#fdbd12\"\/>\n            <circle cx=\"105.88\" cy=\"65.65\" r=\"65.65\" fill=\"#fcba14\"\/>\n            <circle cx=\"111.63\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb715\"\/>\n            <circle cx=\"117.37\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb416\"\/>\n            <circle cx=\"123.12\" cy=\"65.65\" r=\"65.65\" fill=\"#fbb117\"\/>\n            <circle cx=\"128.87\" cy=\"65.65\" r=\"65.65\" fill=\"#fbae18\"\/>\n            <circle cx=\"134.62\" cy=\"65.65\" r=\"65.65\" fill=\"#faac19\"\/>\n            <circle cx=\"140.36\" cy=\"65.65\" r=\"65.65\" fill=\"#faa919\"\/>\n            <circle cx=\"146.11\" cy=\"65.65\" r=\"65.65\" fill=\"#faa61a\"\/>\n            <circle cx=\"151.86\" cy=\"65.65\" r=\"65.65\" fill=\"#faa31b\"\/>\n            <circle cx=\"157.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f9a01b\"\/>\n            <circle cx=\"163.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f99e1c\"\/>\n            <circle cx=\"176.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"191.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"206.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa41a\"\/>\n            <circle cx=\"221.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa719\"\/>\n            <circle cx=\"236.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"251.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"266.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"281.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb316\"\/>\n            <circle cx=\"296.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fdb515\"\/>\n            <circle cx=\"167.34\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb315\"\/>\n            <circle cx=\"171.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"174.82\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"178.56\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"182.3\" cy=\"65.65\" r=\"65.65\" fill=\"#faa819\"\/>\n            <circle cx=\"186.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa51a\"\/>\n            <circle cx=\"189.79\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"193.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"197.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f99c1c\"\/>\n            <circle cx=\"201.01\" cy=\"65.65\" r=\"65.65\" fill=\"#f8991d\"\/>\n            <circle cx=\"204.75\" cy=\"65.65\" r=\"65.65\" fill=\"#f8961d\"\/>\n            <circle cx=\"208.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f7941d\"\/>\n            <circle cx=\"212.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f7911e\"\/>\n            <circle cx=\"215.97\" cy=\"65.65\" r=\"65.65\" fill=\"#f78e1e\"\/>\n            <circle cx=\"219.71\" cy=\"65.65\" r=\"65.65\" fill=\"#f68c1f\"\/>\n            <circle cx=\"223.46\" cy=\"65.65\" r=\"65.65\" fill=\"#f6891f\"\/>\n            <circle cx=\"227.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f6861f\"\/>\n            <circle cx=\"230.94\" cy=\"65.65\" r=\"65.65\" fill=\"#f5831f\"\/>\n            <circle cx=\"234.68\" cy=\"65.65\" r=\"65.65\" fill=\"#f58020\"\/>\n            <circle cx=\"238.42\" cy=\"65.65\" r=\"65.65\" fill=\"#f57e20\"\/>\n            <circle cx=\"242.16\" cy=\"65.65\" r=\"65.65\" fill=\"#f47b20\"\/>\n            <circle cx=\"245.9\" cy=\"65.65\" r=\"65.65\" fill=\"#f47820\"\/>\n            <circle cx=\"249.64\" cy=\"65.65\" r=\"65.65\" fill=\"#f47521\"\/>\n            <circle cx=\"253.38\" cy=\"65.65\" r=\"65.65\" fill=\"#f37221\"\/>\n            <circle cx=\"257.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f36f21\"\/>\n            <circle cx=\"260.87\" cy=\"65.65\" r=\"65.65\" fill=\"#f36c21\"\/>\n            <circle cx=\"266.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"276.54\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"286.84\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"297.14\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"307.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"317.74\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"328.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"338.34\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"348.63\" cy=\"65.65\" r=\"65.65\" fill=\"#f58120\"\/>\n            <circle cx=\"358.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f5841f\"\/>\n            <circle cx=\"369.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"379.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"389.83\" cy=\"65.65\" r=\"65.65\" fill=\"#f78c1e\"\/>\n            <circle cx=\"263.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f78d1e\"\/>\n            <circle cx=\"268.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"273.15\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"278.17\" cy=\"65.65\" r=\"65.65\" fill=\"#f6851f\"\/>\n            <circle cx=\"283.19\" cy=\"65.65\" r=\"65.65\" fill=\"#f58220\"\/>\n            <circle cx=\"288.21\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"293.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"298.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"303.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"308.29\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"313.31\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"318.33\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"323.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"328.37\" cy=\"65.65\" r=\"65.65\" fill=\"#f26722\"\/>\n            <circle cx=\"333.39\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"338.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"343.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f15d22\"\/>\n            <circle cx=\"348.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"353.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f15623\"\/>\n            <circle cx=\"358.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"367.73\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"381.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f15523\"\/>\n            <circle cx=\"394.66\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"408.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f15c22\"\/>\n            <circle cx=\"421.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"435.07\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"448.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f26622\"\/>\n            <circle cx=\"462\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"475.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"488.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"363.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e77625\"\/>\n            <circle cx=\"368.1\" cy=\"65.65\" r=\"65.65\" fill=\"#e87326\"\/>\n            <circle cx=\"372.99\" cy=\"65.65\" r=\"65.65\" fill=\"#e87027\"\/>\n            <circle cx=\"377.89\" cy=\"65.65\" r=\"65.65\" fill=\"#e86e28\"\/>\n            <circle cx=\"382.78\" cy=\"65.65\" r=\"65.65\" fill=\"#e86b29\"\/>\n            <circle cx=\"387.68\" cy=\"65.65\" r=\"65.65\" fill=\"#e9682b\"\/>\n            <circle cx=\"392.57\" cy=\"65.65\" r=\"65.65\" fill=\"#e9652c\"\/>\n            <circle cx=\"397.47\" cy=\"65.65\" r=\"65.65\" fill=\"#e9612d\"\/>\n            <circle cx=\"402.37\" cy=\"65.65\" r=\"65.65\" fill=\"#e95e2e\"\/>\n            <circle cx=\"409.71\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5930\"\/>\n            <circle cx=\"414.6\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5631\"\/>\n            <circle cx=\"419.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5232\"\/>\n            <circle cx=\"424.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4e33\"\/>\n            <circle cx=\"428.07\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b33\"\/>\n            <circle cx=\"432.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4734\"\/>\n            <circle cx=\"437.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4335\"\/>\n            <circle cx=\"442.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ec3f36\"\/>\n            <circle cx=\"447.66\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3a37\"\/>\n            <circle cx=\"452.55\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3537\"\/>\n            <circle cx=\"457.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f38\"\/>\n            <circle cx=\"464.07\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f39\"\/>\n            <circle cx=\"472.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ee353c\"\/>\n            <circle cx=\"480.74\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3a3e\"\/>\n            <circle cx=\"489.08\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3f40\"\/>\n            <circle cx=\"497.41\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4342\"\/>\n            <circle cx=\"505.75\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4744\"\/>\n            <circle cx=\"514.09\" cy=\"65.65\" r=\"65.65\" fill=\"#f04b47\"\/>\n            <circle cx=\"522.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f04f49\"\/>\n            <circle cx=\"530.76\" cy=\"65.65\" r=\"65.65\" fill=\"#f0534b\"\/>\n            <circle cx=\"539.1\" cy=\"65.65\" r=\"65.65\" fill=\"#f1574e\"\/>\n            <circle cx=\"547.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f15b50\"\/>\n            <circle cx=\"555.77\" cy=\"65.65\" r=\"65.65\" fill=\"#f15e53\"\/>\n            <circle cx=\"564.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f16255\"\/>\n            <circle cx=\"572.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f26558\"\/>\n            <circle cx=\"580.78\" cy=\"65.65\" r=\"65.65\" fill=\"#f2695a\"\/>\n            <circle cx=\"589.12\" cy=\"65.65\" r=\"65.65\" fill=\"#f26c5d\"\/>\n            <circle cx=\"462.4\" cy=\"65.65\" r=\"65.65\" fill=\"#f26b5d\"\/>\n            <circle cx=\"467.91\" cy=\"65.65\" r=\"65.65\" fill=\"#f1685d\"\/>\n            <circle cx=\"473.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f0645c\"\/>\n            <circle cx=\"478.92\" cy=\"65.65\" r=\"65.65\" fill=\"#ef615c\"\/>\n            <circle cx=\"484.43\" cy=\"65.65\" r=\"65.65\" fill=\"#ef5d5c\"\/>\n            <circle cx=\"489.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ee595b\"\/>\n            <circle cx=\"495.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ed565b\"\/>\n            <circle cx=\"500.95\" cy=\"65.65\" r=\"65.65\" fill=\"#ed525a\"\/>\n            <circle cx=\"506.46\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e5a\"\/>\n            <circle cx=\"511.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4959\"\/>\n            <circle cx=\"517.48\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4559\"\/>\n            <circle cx=\"522.99\" cy=\"65.65\" r=\"65.65\" fill=\"#ea4159\"\/>\n            <circle cx=\"528.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c58\"\/>\n            <circle cx=\"534\" cy=\"65.65\" r=\"65.65\" fill=\"#e93758\"\/>\n            <circle cx=\"539.51\" cy=\"65.65\" r=\"65.65\" fill=\"#e83157\"\/>\n            <circle cx=\"545.02\" cy=\"65.65\" r=\"65.65\" fill=\"#e82b57\"\/>\n            <circle cx=\"550.53\" cy=\"65.65\" r=\"65.65\" fill=\"#e72456\"\/>\n            <circle cx=\"556.03\" cy=\"65.65\" r=\"65.65\" fill=\"#e71d56\"\/>\n            <circle cx=\"562.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e71b57\"\/>\n            <circle cx=\"569.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e72059\"\/>\n            <circle cx=\"575.84\" cy=\"65.65\" r=\"65.65\" fill=\"#e8255b\"\/>\n            <circle cx=\"582.66\" cy=\"65.65\" r=\"65.65\" fill=\"#e82a5d\"\/>\n            <circle cx=\"589.48\" cy=\"65.65\" r=\"65.65\" fill=\"#e82e5f\"\/>\n            <circle cx=\"596.3\" cy=\"65.65\" r=\"65.65\" fill=\"#e93261\"\/>\n            <circle cx=\"603.12\" cy=\"65.65\" r=\"65.65\" fill=\"#e93664\"\/>\n            <circle cx=\"609.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3966\"\/>\n            <circle cx=\"616.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c68\"\/>\n            <circle cx=\"623.58\" cy=\"65.65\" r=\"65.65\" fill=\"#eb406a\"\/>\n            <circle cx=\"630.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb436d\"\/>\n            <circle cx=\"637.22\" cy=\"65.65\" r=\"65.65\" fill=\"#ec466f\"\/>\n            <circle cx=\"644.04\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4972\"\/>\n            <circle cx=\"650.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4c74\"\/>\n            <circle cx=\"657.68\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4e77\"\/>\n            <circle cx=\"664.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ee5179\"\/>\n            <circle cx=\"671.32\" cy=\"65.65\" r=\"65.65\" fill=\"#ee547c\"\/>\n            <circle cx=\"678.14\" cy=\"65.65\" r=\"65.65\" fill=\"#ef577e\"\/>\n            <circle cx=\"684.96\" cy=\"65.65\" r=\"65.65\" fill=\"#f05981\"\/>\n            <circle cx=\"558.52\" cy=\"65.65\" r=\"65.65\" fill=\"#f05b83\"\/>\n            <circle cx=\"567.62\" cy=\"65.65\" r=\"65.65\" fill=\"#ed5781\"\/>\n            <circle cx=\"576.72\" cy=\"65.65\" r=\"65.65\" fill=\"#eb5380\"\/>\n            <circle cx=\"585.81\" cy=\"65.65\" r=\"65.65\" fill=\"#e94f7e\"\/>\n            <circle cx=\"594.91\" cy=\"65.65\" r=\"65.65\" fill=\"#e74b7d\"\/>\n            <circle cx=\"604.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e5467b\"\/>\n            <circle cx=\"613.11\" cy=\"65.65\" r=\"65.65\" fill=\"#e34279\"\/>\n            <circle cx=\"622.21\" cy=\"65.65\" r=\"65.65\" fill=\"#e13d78\"\/>\n            <circle cx=\"631.31\" cy=\"65.65\" r=\"65.65\" fill=\"#e03977\"\/>\n            <circle cx=\"640.4\" cy=\"65.65\" r=\"65.65\" fill=\"#de3375\"\/>\n            <circle cx=\"649.5\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2e74\"\/>\n            <circle cx=\"658.6\" cy=\"65.65\" r=\"65.65\" fill=\"#db2772\"\/>\n            <circle cx=\"667.7\" cy=\"65.65\" r=\"65.65\" fill=\"#d92171\"\/>\n            <circle cx=\"676.8\" cy=\"65.65\" r=\"65.65\" fill=\"#d71970\"\/>\n            <circle cx=\"682.15\" cy=\"65.65\" r=\"65.65\" fill=\"#d81a71\"\/>\n            <circle cx=\"686.25\" cy=\"65.65\" r=\"65.65\" fill=\"#d91e73\"\/>\n            <circle cx=\"690.35\" cy=\"65.65\" r=\"65.65\" fill=\"#da2275\"\/>\n            <circle cx=\"694.45\" cy=\"65.65\" r=\"65.65\" fill=\"#db2577\"\/>\n            <circle cx=\"698.55\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2979\"\/>\n            <circle cx=\"702.65\" cy=\"65.65\" r=\"65.65\" fill=\"#dd2c7b\"\/>\n            <circle cx=\"706.75\" cy=\"65.65\" r=\"65.65\" fill=\"#df2f7d\"\/>\n            <circle cx=\"710.85\" cy=\"65.65\" r=\"65.65\" fill=\"#e03280\"\/>\n            <circle cx=\"714.95\" cy=\"65.65\" r=\"65.65\" fill=\"#e13582\"\/>\n            <circle cx=\"719.05\" cy=\"65.65\" r=\"65.65\" fill=\"#e23884\"\/>\n            <circle cx=\"723.15\" cy=\"65.65\" r=\"65.65\" fill=\"#e33b87\"\/>\n            <circle cx=\"727.25\" cy=\"65.65\" r=\"65.65\" fill=\"#e43e89\"\/>\n            <circle cx=\"731.35\" cy=\"65.65\" r=\"65.65\" fill=\"#e5408b\"\/>\n            <circle cx=\"735.45\" cy=\"65.65\" r=\"65.65\" fill=\"#e6438e\"\/>\n            <circle cx=\"739.55\" cy=\"65.65\" r=\"65.65\" fill=\"#e84690\"\/>\n            <circle cx=\"743.65\" cy=\"65.65\" r=\"65.65\" fill=\"#e94893\"\/>\n            <circle cx=\"747.75\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b96\"\/>\n            <circle cx=\"751.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e99\"\/>\n            <circle cx=\"757.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ef509d\"\/>\n    <\/svg>\n<\/div>\n\n        \n    <\/div>\n    <div class=\"rqm-divider-mobile\">\n        <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/rqm-dots-mobile.avif\" alt=\"\" width=\"427\" height=\"40\" \/>\n    <\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\">\n<p>Combination products represent the forefront of innovation, merging the best of drug, biologic, and device technologies to revolutionize patient care. However, their complexity demands expert integration of regulatory, clinical, and commercialization strategies. RQM+ is your combination product consulting lifeline, uniquely positioned to guide you through the product life cycle from start to finish.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Our solutions for combination products ensure compliance, optimize performance, and accelerate patient access.&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"\/contact\/\">Start Now&nbsp;<\/a><\/div>\n<\/div>\n<\/div>\n\n\n<section id=\"content-list-block_878079a9b832b76d3159c825016cf784\" class=\"block-content-list alignwide has-image\">\n    \n    <style>\n                #content-list-block_878079a9b832b76d3159c825016cf784 .clb-image {\n            background: url(https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/several-people-in-a-ameeting.jpg) center center \/ cover no-repeat;\n        }\n            <\/style>\n\n\n    <div class=\"content-list-block-container\">\n        <div class=\"clb-bg clb-bg-1\"><\/div>\n        <div class=\"clb-bg clb-bg-2\"><\/div>\n        <div class=\"clb-inside\">\n            \n            <div class=\"clb-header\">\n                \n\n<h2 class=\"wp-block-heading pink-header has-pink-color has-text-color has-link-color wp-elements-b02a656e93cefb1df4761738f8da4d9e\"><strong><strong><strong><strong>Combination Products Consulting Benefits<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n            <\/div>\n            <div class=\"clb-list\">\n                <div class=\"wp-block-columns\">\n                    <div class=\"wp-block-column\">\n    \n                        <ul>\n                                                                \n                                        \n                                    <li id=\"content-list-block_878079a9b832b76d3159c825016cf784-row-0\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/checkboard-checkmark.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Regulatory Integration<\/h3>\n                                            <p class=\"list-text\">Expertise in navigating dual regulatory pathways for FDA and global submissions.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_878079a9b832b76d3159c825016cf784-row-1\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/connected-hexagon.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Comprehensive Support<\/h3>\n                                            <p class=\"list-text\">Customized solutions across consulting, clinical trials, lab services, and reimbursement.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_878079a9b832b76d3159c825016cf784-row-2\" class=\"icon-area content-list-row\">\n                                        <div class=\"content-list-row-bg\"><\/div>\n                                        <div class=\"icon-outer-container\">\n                                            <div class=\"icon-container icon-echo\">\n                                                                                                    <img decoding=\"async\" class=\"icon\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/speedometer.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Accelerated Market Access<\/h3>\n                                            <p class=\"list-text\">Highly efficient processes to ensure your combination product reaches patients faster.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                        <\/ul>\n    \n                    <\/div>\n                                            <div class=\"wp-block-column\" style=\"flex-basis: 40%;\">\n                            <div class=\"clb-image-contain\">\n                                <div class=\"clb-image clb-img-echo\"><\/div>\n                            <\/div>\n                        <\/div>\n                                        \n                <\/div>\n            <\/div>\n            \n        <\/div>\n        \n    <\/div>\n<\/section>\n\n\n<div id=\"rqm-group-block_712f0b3684ffa2dbe2a79779779991dc\" class=\"block-rqm-group alignfull\" style=\"background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-right.avif'), url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-left.avif');background-position: right bottom -30em, left top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n\n<div class=\"wp-block-group alignwide has-border-color has-pink-border-color is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px;padding-bottom:0px\"><div id=\"rqm-heading-block_a4a828f736295d92e76a45472fb92458\" class=\"block-rqm-heading rqm-dots-animate\">\n    <div class=\"rqm-heading\">\n        <div class=\"rqm-dots-divider\" style=\"display:flex;gap:50px;width:1253px;\">\n    <svg class=\"rqm-dots\" viewBox=\"0 0 503.26 131.31\" aria-hidden=\"true\" height=\"118\" width=\"451\" style=\"display:block;\">\n        <g class=\"dots-start\" fill=\"#ffce06\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"251.63\" cy=\"65.65\" r=\"65.65\"\/>\n            <circle cx=\"437.61\" cy=\"65.65\" r=\"65.65\"\/>\n        <\/g>\n    <\/svg>\n    <svg class=\"rqm-dots-grad\" viewBox=\"0 0 823.14 131.31\" aria-hidden=\"true\" height=\"118\" width=\"752\" style=\"display:block; border-radius: 50px;\" preserveAspectRatio=\"xMaxYMid slice\">\n            <circle cx=\"65.65\" cy=\"65.65\" r=\"65.65\" fill=\"#ffce06\"\/>\n            <circle cx=\"71.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ffcb08\"\/>\n            <circle cx=\"77.15\" cy=\"65.65\" r=\"65.65\" fill=\"#fec80b\"\/>\n            <circle cx=\"82.89\" cy=\"65.65\" r=\"65.65\" fill=\"#fec50d\"\/>\n            <circle cx=\"88.64\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc20f\"\/>\n            <circle cx=\"94.39\" cy=\"65.65\" r=\"65.65\" fill=\"#fdc011\"\/>\n            <circle cx=\"100.13\" cy=\"65.65\" r=\"65.65\" fill=\"#fdbd12\"\/>\n            <circle cx=\"105.88\" cy=\"65.65\" r=\"65.65\" fill=\"#fcba14\"\/>\n            <circle cx=\"111.63\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb715\"\/>\n            <circle cx=\"117.37\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb416\"\/>\n            <circle cx=\"123.12\" cy=\"65.65\" r=\"65.65\" fill=\"#fbb117\"\/>\n            <circle cx=\"128.87\" cy=\"65.65\" r=\"65.65\" fill=\"#fbae18\"\/>\n            <circle cx=\"134.62\" cy=\"65.65\" r=\"65.65\" fill=\"#faac19\"\/>\n            <circle cx=\"140.36\" cy=\"65.65\" r=\"65.65\" fill=\"#faa919\"\/>\n            <circle cx=\"146.11\" cy=\"65.65\" r=\"65.65\" fill=\"#faa61a\"\/>\n            <circle cx=\"151.86\" cy=\"65.65\" r=\"65.65\" fill=\"#faa31b\"\/>\n            <circle cx=\"157.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f9a01b\"\/>\n            <circle cx=\"163.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f99e1c\"\/>\n            <circle cx=\"176.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"191.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"206.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa41a\"\/>\n            <circle cx=\"221.06\" cy=\"65.65\" r=\"65.65\" fill=\"#faa719\"\/>\n            <circle cx=\"236.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"251.07\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"266.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"281.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb316\"\/>\n            <circle cx=\"296.09\" cy=\"65.65\" r=\"65.65\" fill=\"#fdb515\"\/>\n            <circle cx=\"167.34\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb315\"\/>\n            <circle cx=\"171.08\" cy=\"65.65\" r=\"65.65\" fill=\"#fcb017\"\/>\n            <circle cx=\"174.82\" cy=\"65.65\" r=\"65.65\" fill=\"#fbad18\"\/>\n            <circle cx=\"178.56\" cy=\"65.65\" r=\"65.65\" fill=\"#fbaa19\"\/>\n            <circle cx=\"182.3\" cy=\"65.65\" r=\"65.65\" fill=\"#faa819\"\/>\n            <circle cx=\"186.05\" cy=\"65.65\" r=\"65.65\" fill=\"#faa51a\"\/>\n            <circle cx=\"189.79\" cy=\"65.65\" r=\"65.65\" fill=\"#faa21b\"\/>\n            <circle cx=\"193.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f99f1b\"\/>\n            <circle cx=\"197.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f99c1c\"\/>\n            <circle cx=\"201.01\" cy=\"65.65\" r=\"65.65\" fill=\"#f8991d\"\/>\n            <circle cx=\"204.75\" cy=\"65.65\" r=\"65.65\" fill=\"#f8961d\"\/>\n            <circle cx=\"208.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f7941d\"\/>\n            <circle cx=\"212.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f7911e\"\/>\n            <circle cx=\"215.97\" cy=\"65.65\" r=\"65.65\" fill=\"#f78e1e\"\/>\n            <circle cx=\"219.71\" cy=\"65.65\" r=\"65.65\" fill=\"#f68c1f\"\/>\n            <circle cx=\"223.46\" cy=\"65.65\" r=\"65.65\" fill=\"#f6891f\"\/>\n            <circle cx=\"227.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f6861f\"\/>\n            <circle cx=\"230.94\" cy=\"65.65\" r=\"65.65\" fill=\"#f5831f\"\/>\n            <circle cx=\"234.68\" cy=\"65.65\" r=\"65.65\" fill=\"#f58020\"\/>\n            <circle cx=\"238.42\" cy=\"65.65\" r=\"65.65\" fill=\"#f57e20\"\/>\n            <circle cx=\"242.16\" cy=\"65.65\" r=\"65.65\" fill=\"#f47b20\"\/>\n            <circle cx=\"245.9\" cy=\"65.65\" r=\"65.65\" fill=\"#f47820\"\/>\n            <circle cx=\"249.64\" cy=\"65.65\" r=\"65.65\" fill=\"#f47521\"\/>\n            <circle cx=\"253.38\" cy=\"65.65\" r=\"65.65\" fill=\"#f37221\"\/>\n            <circle cx=\"257.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f36f21\"\/>\n            <circle cx=\"260.87\" cy=\"65.65\" r=\"65.65\" fill=\"#f36c21\"\/>\n            <circle cx=\"266.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"276.54\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"286.84\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"297.14\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"307.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"317.74\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"328.04\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"338.34\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"348.63\" cy=\"65.65\" r=\"65.65\" fill=\"#f58120\"\/>\n            <circle cx=\"358.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f5841f\"\/>\n            <circle cx=\"369.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"379.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"389.83\" cy=\"65.65\" r=\"65.65\" fill=\"#f78c1e\"\/>\n            <circle cx=\"263.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f78d1e\"\/>\n            <circle cx=\"268.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f68a1f\"\/>\n            <circle cx=\"273.15\" cy=\"65.65\" r=\"65.65\" fill=\"#f6871f\"\/>\n            <circle cx=\"278.17\" cy=\"65.65\" r=\"65.65\" fill=\"#f6851f\"\/>\n            <circle cx=\"283.19\" cy=\"65.65\" r=\"65.65\" fill=\"#f58220\"\/>\n            <circle cx=\"288.21\" cy=\"65.65\" r=\"65.65\" fill=\"#f57f20\"\/>\n            <circle cx=\"293.23\" cy=\"65.65\" r=\"65.65\" fill=\"#f47c20\"\/>\n            <circle cx=\"298.25\" cy=\"65.65\" r=\"65.65\" fill=\"#f47920\"\/>\n            <circle cx=\"303.27\" cy=\"65.65\" r=\"65.65\" fill=\"#f47621\"\/>\n            <circle cx=\"308.29\" cy=\"65.65\" r=\"65.65\" fill=\"#f37321\"\/>\n            <circle cx=\"313.31\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"318.33\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"323.35\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"328.37\" cy=\"65.65\" r=\"65.65\" fill=\"#f26722\"\/>\n            <circle cx=\"333.39\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"338.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"343.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f15d22\"\/>\n            <circle cx=\"348.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"353.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f15623\"\/>\n            <circle cx=\"358.49\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"367.73\" cy=\"65.65\" r=\"65.65\" fill=\"#f05223\"\/>\n            <circle cx=\"381.2\" cy=\"65.65\" r=\"65.65\" fill=\"#f15523\"\/>\n            <circle cx=\"394.66\" cy=\"65.65\" r=\"65.65\" fill=\"#f15922\"\/>\n            <circle cx=\"408.13\" cy=\"65.65\" r=\"65.65\" fill=\"#f15c22\"\/>\n            <circle cx=\"421.6\" cy=\"65.65\" r=\"65.65\" fill=\"#f16022\"\/>\n            <circle cx=\"435.07\" cy=\"65.65\" r=\"65.65\" fill=\"#f26322\"\/>\n            <circle cx=\"448.53\" cy=\"65.65\" r=\"65.65\" fill=\"#f26622\"\/>\n            <circle cx=\"462\" cy=\"65.65\" r=\"65.65\" fill=\"#f26a21\"\/>\n            <circle cx=\"475.47\" cy=\"65.65\" r=\"65.65\" fill=\"#f36d21\"\/>\n            <circle cx=\"488.93\" cy=\"65.65\" r=\"65.65\" fill=\"#f37021\"\/>\n            <circle cx=\"363.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e77625\"\/>\n            <circle cx=\"368.1\" cy=\"65.65\" r=\"65.65\" fill=\"#e87326\"\/>\n            <circle cx=\"372.99\" cy=\"65.65\" r=\"65.65\" fill=\"#e87027\"\/>\n            <circle cx=\"377.89\" cy=\"65.65\" r=\"65.65\" fill=\"#e86e28\"\/>\n            <circle cx=\"382.78\" cy=\"65.65\" r=\"65.65\" fill=\"#e86b29\"\/>\n            <circle cx=\"387.68\" cy=\"65.65\" r=\"65.65\" fill=\"#e9682b\"\/>\n            <circle cx=\"392.57\" cy=\"65.65\" r=\"65.65\" fill=\"#e9652c\"\/>\n            <circle cx=\"397.47\" cy=\"65.65\" r=\"65.65\" fill=\"#e9612d\"\/>\n            <circle cx=\"402.37\" cy=\"65.65\" r=\"65.65\" fill=\"#e95e2e\"\/>\n            <circle cx=\"409.71\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5930\"\/>\n            <circle cx=\"414.6\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5631\"\/>\n            <circle cx=\"419.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ea5232\"\/>\n            <circle cx=\"424.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4e33\"\/>\n            <circle cx=\"428.07\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b33\"\/>\n            <circle cx=\"432.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4734\"\/>\n            <circle cx=\"437.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4335\"\/>\n            <circle cx=\"442.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ec3f36\"\/>\n            <circle cx=\"447.66\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3a37\"\/>\n            <circle cx=\"452.55\" cy=\"65.65\" r=\"65.65\" fill=\"#ed3537\"\/>\n            <circle cx=\"457.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f38\"\/>\n            <circle cx=\"464.07\" cy=\"65.65\" r=\"65.65\" fill=\"#ee2f39\"\/>\n            <circle cx=\"472.4\" cy=\"65.65\" r=\"65.65\" fill=\"#ee353c\"\/>\n            <circle cx=\"480.74\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3a3e\"\/>\n            <circle cx=\"489.08\" cy=\"65.65\" r=\"65.65\" fill=\"#ef3f40\"\/>\n            <circle cx=\"497.41\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4342\"\/>\n            <circle cx=\"505.75\" cy=\"65.65\" r=\"65.65\" fill=\"#ef4744\"\/>\n            <circle cx=\"514.09\" cy=\"65.65\" r=\"65.65\" fill=\"#f04b47\"\/>\n            <circle cx=\"522.43\" cy=\"65.65\" r=\"65.65\" fill=\"#f04f49\"\/>\n            <circle cx=\"530.76\" cy=\"65.65\" r=\"65.65\" fill=\"#f0534b\"\/>\n            <circle cx=\"539.1\" cy=\"65.65\" r=\"65.65\" fill=\"#f1574e\"\/>\n            <circle cx=\"547.44\" cy=\"65.65\" r=\"65.65\" fill=\"#f15b50\"\/>\n            <circle cx=\"555.77\" cy=\"65.65\" r=\"65.65\" fill=\"#f15e53\"\/>\n            <circle cx=\"564.11\" cy=\"65.65\" r=\"65.65\" fill=\"#f16255\"\/>\n            <circle cx=\"572.45\" cy=\"65.65\" r=\"65.65\" fill=\"#f26558\"\/>\n            <circle cx=\"580.78\" cy=\"65.65\" r=\"65.65\" fill=\"#f2695a\"\/>\n            <circle cx=\"589.12\" cy=\"65.65\" r=\"65.65\" fill=\"#f26c5d\"\/>\n            <circle cx=\"462.4\" cy=\"65.65\" r=\"65.65\" fill=\"#f26b5d\"\/>\n            <circle cx=\"467.91\" cy=\"65.65\" r=\"65.65\" fill=\"#f1685d\"\/>\n            <circle cx=\"473.41\" cy=\"65.65\" r=\"65.65\" fill=\"#f0645c\"\/>\n            <circle cx=\"478.92\" cy=\"65.65\" r=\"65.65\" fill=\"#ef615c\"\/>\n            <circle cx=\"484.43\" cy=\"65.65\" r=\"65.65\" fill=\"#ef5d5c\"\/>\n            <circle cx=\"489.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ee595b\"\/>\n            <circle cx=\"495.45\" cy=\"65.65\" r=\"65.65\" fill=\"#ed565b\"\/>\n            <circle cx=\"500.95\" cy=\"65.65\" r=\"65.65\" fill=\"#ed525a\"\/>\n            <circle cx=\"506.46\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e5a\"\/>\n            <circle cx=\"511.97\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4959\"\/>\n            <circle cx=\"517.48\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4559\"\/>\n            <circle cx=\"522.99\" cy=\"65.65\" r=\"65.65\" fill=\"#ea4159\"\/>\n            <circle cx=\"528.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c58\"\/>\n            <circle cx=\"534\" cy=\"65.65\" r=\"65.65\" fill=\"#e93758\"\/>\n            <circle cx=\"539.51\" cy=\"65.65\" r=\"65.65\" fill=\"#e83157\"\/>\n            <circle cx=\"545.02\" cy=\"65.65\" r=\"65.65\" fill=\"#e82b57\"\/>\n            <circle cx=\"550.53\" cy=\"65.65\" r=\"65.65\" fill=\"#e72456\"\/>\n            <circle cx=\"556.03\" cy=\"65.65\" r=\"65.65\" fill=\"#e71d56\"\/>\n            <circle cx=\"562.19\" cy=\"65.65\" r=\"65.65\" fill=\"#e71b57\"\/>\n            <circle cx=\"569.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e72059\"\/>\n            <circle cx=\"575.84\" cy=\"65.65\" r=\"65.65\" fill=\"#e8255b\"\/>\n            <circle cx=\"582.66\" cy=\"65.65\" r=\"65.65\" fill=\"#e82a5d\"\/>\n            <circle cx=\"589.48\" cy=\"65.65\" r=\"65.65\" fill=\"#e82e5f\"\/>\n            <circle cx=\"596.3\" cy=\"65.65\" r=\"65.65\" fill=\"#e93261\"\/>\n            <circle cx=\"603.12\" cy=\"65.65\" r=\"65.65\" fill=\"#e93664\"\/>\n            <circle cx=\"609.94\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3966\"\/>\n            <circle cx=\"616.76\" cy=\"65.65\" r=\"65.65\" fill=\"#ea3c68\"\/>\n            <circle cx=\"623.58\" cy=\"65.65\" r=\"65.65\" fill=\"#eb406a\"\/>\n            <circle cx=\"630.4\" cy=\"65.65\" r=\"65.65\" fill=\"#eb436d\"\/>\n            <circle cx=\"637.22\" cy=\"65.65\" r=\"65.65\" fill=\"#ec466f\"\/>\n            <circle cx=\"644.04\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4972\"\/>\n            <circle cx=\"650.86\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4c74\"\/>\n            <circle cx=\"657.68\" cy=\"65.65\" r=\"65.65\" fill=\"#ed4e77\"\/>\n            <circle cx=\"664.5\" cy=\"65.65\" r=\"65.65\" fill=\"#ee5179\"\/>\n            <circle cx=\"671.32\" cy=\"65.65\" r=\"65.65\" fill=\"#ee547c\"\/>\n            <circle cx=\"678.14\" cy=\"65.65\" r=\"65.65\" fill=\"#ef577e\"\/>\n            <circle cx=\"684.96\" cy=\"65.65\" r=\"65.65\" fill=\"#f05981\"\/>\n            <circle cx=\"558.52\" cy=\"65.65\" r=\"65.65\" fill=\"#f05b83\"\/>\n            <circle cx=\"567.62\" cy=\"65.65\" r=\"65.65\" fill=\"#ed5781\"\/>\n            <circle cx=\"576.72\" cy=\"65.65\" r=\"65.65\" fill=\"#eb5380\"\/>\n            <circle cx=\"585.81\" cy=\"65.65\" r=\"65.65\" fill=\"#e94f7e\"\/>\n            <circle cx=\"594.91\" cy=\"65.65\" r=\"65.65\" fill=\"#e74b7d\"\/>\n            <circle cx=\"604.01\" cy=\"65.65\" r=\"65.65\" fill=\"#e5467b\"\/>\n            <circle cx=\"613.11\" cy=\"65.65\" r=\"65.65\" fill=\"#e34279\"\/>\n            <circle cx=\"622.21\" cy=\"65.65\" r=\"65.65\" fill=\"#e13d78\"\/>\n            <circle cx=\"631.31\" cy=\"65.65\" r=\"65.65\" fill=\"#e03977\"\/>\n            <circle cx=\"640.4\" cy=\"65.65\" r=\"65.65\" fill=\"#de3375\"\/>\n            <circle cx=\"649.5\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2e74\"\/>\n            <circle cx=\"658.6\" cy=\"65.65\" r=\"65.65\" fill=\"#db2772\"\/>\n            <circle cx=\"667.7\" cy=\"65.65\" r=\"65.65\" fill=\"#d92171\"\/>\n            <circle cx=\"676.8\" cy=\"65.65\" r=\"65.65\" fill=\"#d71970\"\/>\n            <circle cx=\"682.15\" cy=\"65.65\" r=\"65.65\" fill=\"#d81a71\"\/>\n            <circle cx=\"686.25\" cy=\"65.65\" r=\"65.65\" fill=\"#d91e73\"\/>\n            <circle cx=\"690.35\" cy=\"65.65\" r=\"65.65\" fill=\"#da2275\"\/>\n            <circle cx=\"694.45\" cy=\"65.65\" r=\"65.65\" fill=\"#db2577\"\/>\n            <circle cx=\"698.55\" cy=\"65.65\" r=\"65.65\" fill=\"#dc2979\"\/>\n            <circle cx=\"702.65\" cy=\"65.65\" r=\"65.65\" fill=\"#dd2c7b\"\/>\n            <circle cx=\"706.75\" cy=\"65.65\" r=\"65.65\" fill=\"#df2f7d\"\/>\n            <circle cx=\"710.85\" cy=\"65.65\" r=\"65.65\" fill=\"#e03280\"\/>\n            <circle cx=\"714.95\" cy=\"65.65\" r=\"65.65\" fill=\"#e13582\"\/>\n            <circle cx=\"719.05\" cy=\"65.65\" r=\"65.65\" fill=\"#e23884\"\/>\n            <circle cx=\"723.15\" cy=\"65.65\" r=\"65.65\" fill=\"#e33b87\"\/>\n            <circle cx=\"727.25\" cy=\"65.65\" r=\"65.65\" fill=\"#e43e89\"\/>\n            <circle cx=\"731.35\" cy=\"65.65\" r=\"65.65\" fill=\"#e5408b\"\/>\n            <circle cx=\"735.45\" cy=\"65.65\" r=\"65.65\" fill=\"#e6438e\"\/>\n            <circle cx=\"739.55\" cy=\"65.65\" r=\"65.65\" fill=\"#e84690\"\/>\n            <circle cx=\"743.65\" cy=\"65.65\" r=\"65.65\" fill=\"#e94893\"\/>\n            <circle cx=\"747.75\" cy=\"65.65\" r=\"65.65\" fill=\"#eb4b96\"\/>\n            <circle cx=\"751.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ec4e99\"\/>\n            <circle cx=\"757.49\" cy=\"65.65\" r=\"65.65\" fill=\"#ef509d\"\/>\n    <\/svg>\n<\/div>\n\n        <div class=\"rqm-heading-bg\"><\/div>\n        \n\n<h2 class=\"wp-block-heading\"><strong>Integrated Life Cycle Approach: Beyond Compliance<\/strong><\/h2>\n\n  \n    <\/div>\n<\/div>\n\n\n\n<p>Combination products require both regulatory clearance and alignment across development, testing, and post-market phases. RQM+ supports you throughout the entire life cycle, ensuring compliance at every stage while optimizing speed to market:<\/p>\n\n\n<div id=\"rqm-list-block_1e46828b2b522dff792ac9ae24dab92a\" class=\"block-rqm-list\">\n\n    <ul class=\"rqm-list\">\n        \n<li id=\"rqm-list-item-block_ab7e0b9399061f9bc154db1b9890e98f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Development<\/h3>\n\n\n\n<p>Strategic planning to meet drug-device combination requirements<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_ab7e0b9399061f9bc154db1b9890e98f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Testing<\/h3>\n\n\n\n<p>Integrated biocompatibility and chemical characterization tailored to combination products<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_ab7e0b9399061f9bc154db1b9890e98f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Market entry<\/h3>\n\n\n\n<p>Comprehensive submission packages and agency liaison<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_ab7e0b9399061f9bc154db1b9890e98f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Post-market<\/h3>\n\n\n\n<p>Ongoing compliance monitoring and reporting aligned with MDR and FDA standards<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_ab7e0b9399061f9bc154db1b9890e98f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Gold standard lab<br>&amp; material science<\/h3>\n\n\n\n<p>Industry-leading materials testing and chemical characterization recognized by the FDA<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_ab7e0b9399061f9bc154db1b9890e98f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Global reach<\/h3>\n\n\n\n<p>Successful regulatory submissions across the U.S., Europe, and the U.K.<\/p>\n\n       \n<\/li>\n\n\n    <\/ul>\n\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n<div id=\"rqm-group-block_712f0b3684ffa2dbe2a79779779991dc\" class=\"block-rqm-group alignfull\" style=\"background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-right.avif'), url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-left.avif');background-position: right bottom -30em, left top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-5628178f1f3ff7b9ff80bb98d536f913\"><strong>Flexible Partnering Solutions<\/strong><\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"800\" height=\"533\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing.jpg\" alt=\"Full-Service Outsourcing\" class=\"wp-image-1301\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing.jpg 800w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/full-service-outsourcing-768x512.jpg 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Outsourcing<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Customizable and scalable outsourcing scoped for entire projects, specific functions, or defined parts of a function. Leverage RQM+ expertise and flexibility while your teams stay focused on core competencies, corporate goals, and innovation. <a href=\"https:\/\/www.rqmplus.com\/contact\/\">Partner with us.<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large has-custom-border\"><a href=\"\/contact\/\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1024x683.jpg\" alt=\"Professional Consulting\" class=\"wp-image-976\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1024x683.jpg 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-768x512.jpg 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper-1536x1024.jpg 1536w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-paper.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Consulting<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Targeted, outcome-focused expertise to solve defined MedTech challenges. RQM+<br>consultants step in with practical, actionable guidance and hands-on execution to drive timely resolution. <a href=\"https:\/\/www.rqmplus.com\/contact\/\">Partner with us.<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-large has-custom-border\"><a href=\"\/match-with-a-contractor\/\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1024x683.jpg\" alt=\"Professional Staffing\" class=\"wp-image-1223\" style=\"border-top-left-radius:0px;border-top-right-radius:32px;border-bottom-left-radius:32px;border-bottom-right-radius:32px\" srcset=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1024x683.jpg 1024w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-300x200.jpg 300w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-768x512.jpg 768w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611-1536x1024.jpg 1536w, https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/04\/shutterstock_2552581611.jpg 1800w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n\n\n\n<h3 class=\"wp-block-heading has-heading-4-font-size\">Staff Augmentation<\/h3>\n\n\n\n<p class=\"has-small-font-size\">Fill skill or capacity gaps with MedTech talent from RQM+. We provide on-demand<br>professionals, functional service support, fast deployment for tight timelines, and<br>contract-to-hire options that integrate seamlessly with your team. <a href=\"https:\/\/www.rqmplus.com\/match-with-a-contractor\/\">Match with a contractor.<\/a><\/p>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n<div id=\"lifecyclesupport\" class=\"block-rqm-group alignfull\" style=\"padding-top: 0px; background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-left.avif'), url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-right.avif');background-position: left bottom -30em, right top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n\n<div class=\"wp-block-group alignwide is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px;padding-bottom:0px\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-2a249317e5651da6ca9c639150b1e4f3\"><strong><strong><strong>Life Cycle Support<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Expand each to see key services.<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>.kt-accordion-id26_c98b4d-be .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:0px;padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id26_c98b4d-be .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;border-top-right-radius:40px;border-bottom-right-radius:40px;border-bottom-left-radius:40px;background:#fff;font-size:30px;text-transform:none;color:#062464;padding-top:40px;padding-right:32px;padding-bottom:40px;padding-left:32px;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner, .kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner h1, .kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner h2, .kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner h3, .kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner h4, .kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner h5, .kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner h6{color:#062464;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#062464;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_c98b4d-be:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id26_c98b4d-be .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 1024px){.kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 767px){.kt-accordion-id26_c98b4d-be .kt-accordion-inner-wrap{display:block;}.kt-accordion-id26_c98b4d-be .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id26_c98b4d-be .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id26_c98b4d-be .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_c98b4d-be .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id26_c98b4d-be kt-accordion-has-7-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane26_78167c-87\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">1. Design Concept<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Product classification (drug vs. device vs. biologic-led)&nbsp;<\/li>\n\n\n\n<li>Primary mode of action (PMOA) analysis&nbsp;<\/li>\n\n\n\n<li>Jurisdiction strategy (CDRH\/CDER\/CBER, EMA, NCAs)&nbsp;<\/li>\n\n\n\n<li>FDA Intercenter Consult Request (ICCR) planning&nbsp;<\/li>\n\n\n\n<li>EU: Borderline determination, EMA consultation&nbsp;<\/li>\n\n\n\n<li>Global regulatory pathway strategy&nbsp;<br><strong>Documents:<\/strong> Regulatory strategy memo, PMOA justification, briefing documents&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Risk management plan (ISO 14971)&nbsp;<\/li>\n\n\n\n<li>Combination product development framework alignment&nbsp;<\/li>\n\n\n\n<li>Device constituent quality planning&nbsp;<\/li>\n\n\n\n<li>cGMP vs. QSR mapping&nbsp;<br><strong>Documents:<\/strong> Risk management plan, combination product quality plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Early feasibility assessments&nbsp;<\/li>\n\n\n\n<li>Clinical development plan concept (drug + device integration)&nbsp;<\/li>\n\n\n\n<li>Human factors planning&nbsp;<br><strong>Documents:<\/strong> Draft CDP, early clinical plan outline&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Combination product market and value proposition assessment&nbsp;<\/li>\n\n\n\n<li>Reimbursement landscape across drug and device pathways&nbsp;<br><strong>Documents:<\/strong> Early reimbursement strategy memo, HTA readiness assessment&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Material selection and formulation consulting&nbsp;<\/li>\n\n\n\n<li>Extractables\/leachables strategy setup&nbsp;<br><strong>Documents:<\/strong> Material justification report, E\/L testing strategy&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Draft TPP (Target Product Profile) including drug\/device attributes&nbsp;<\/li>\n\n\n\n<li>Early IFU\/label concept drafts&nbsp;<br><strong>Documents:<\/strong> TPP draft, outline of clinical utility rationale<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane26_37070a-f6\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">2. Design &amp; Development<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Meeting requests and briefing packages (FDA\/EMA)&nbsp;<\/li>\n\n\n\n<li>Combination product classification confirmation&nbsp;<\/li>\n\n\n\n<li>IND vs. IDE determination (US)&nbsp;<\/li>\n\n\n\n<li>EMA drug-device consultation support&nbsp;<br><strong>Documents:<\/strong> Pre-sub\/Q-Sub packets, EMA consultation dossiers&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Design control documentation for device constituent&nbsp;<\/li>\n\n\n\n<li>Integration of cGMP\/QSR\/QMS hybrid system&nbsp;<\/li>\n\n\n\n<li>Supplier and component traceability&nbsp;<br><strong>Documents:<\/strong> DHF, DMR drafts, QMS alignment plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Protocol design with drug-device endpoints&nbsp;<\/li>\n\n\n\n<li>Safety reporting structure planning (both CDER and CDRH\/CDER split)&nbsp;<br><strong>Documents:<\/strong> Draft protocol, safety reporting SOPs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Evidence-to-value strategy for hybrid pathways&nbsp;<\/li>\n\n\n\n<li>Companion diagnostic and delivery method considerations&nbsp;<br><strong>Documents:<\/strong> Reimbursement roadmap, payer messaging alignment&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Extractables and leachables method development&nbsp;<\/li>\n\n\n\n<li>Container\/closure system compatibility&nbsp;<br><strong>Documents:<\/strong> Testing protocol, method validation reports (support only)&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Protocol authorship&nbsp;<\/li>\n\n\n\n<li>Risk-benefit narrative development&nbsp;<br><strong>Documents:<\/strong> Draft protocol, target labeling document&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane26_ba8b08-c7\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">3. Verification &amp; Validation<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Verification and validation planning support (not execution)&nbsp;<\/li>\n\n\n\n<li>Device constituent regulatory impact assessment&nbsp;<br><strong>Documents:<\/strong> Verification planning rationale, validation summary memo&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Test method documentation support&nbsp;<\/li>\n\n\n\n<li>Design validation documentation (support only)&nbsp;<br><strong>Documents:<\/strong> TMV protocol support, validation documentation templates&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Final protocol completion&nbsp;<\/li>\n\n\n\n<li>Site qualification planning&nbsp;<br><strong>Documents:<\/strong> Final protocol, monitoring plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Coding implications of product configuration&nbsp;<br><strong>Documents:<\/strong> Coding rationale document&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Execution of E&amp;L testing, biocompatibility&nbsp;<\/li>\n\n\n\n<li>ISO 10993 testing strategy&nbsp;<br><strong>Documents:<\/strong> Biocompatibility reports, E\/L test reports&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>IFU drafts with validated content&nbsp;<\/li>\n\n\n\n<li>Risk-based justification summaries&nbsp;<br><strong>Documents:<\/strong> IFU, Instructions for administration\/use, Safety summary&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane26_05de4b-b7\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">4. Clinical Evidence Generation<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Clinical trial submission support (IND, IDE, CTAs)&nbsp;<\/li>\n\n\n\n<li>Risk-based monitoring strategy consultation&nbsp;<br><strong>Documents:<\/strong> Clinical protocol, IND\/IDE\/CTA documentation&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Clinical quality SOPs&nbsp;<\/li>\n\n\n\n<li>GCP compliance guidance&nbsp;<br><strong>Documents:<\/strong> Clinical SOPs, monitoring logs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Full trial execution (project management, monitoring, data management)&nbsp;<\/li>\n\n\n\n<li>Real-world evidence setup if applicable&nbsp;<br><strong>Documents:<\/strong> CSR, study reports, safety summaries&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Clinical value justification&nbsp;<\/li>\n\n\n\n<li>Economic endpoint strategy&nbsp;<br><strong>Documents:<\/strong> Value dossier contributions&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Stability testing&nbsp;<\/li>\n\n\n\n<li>Product interaction evaluations&nbsp;<br><strong>Documents:<\/strong> Stability report, compatibility analysis&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>CSR development&nbsp;<\/li>\n\n\n\n<li>Clinical summaries for regulatory submission&nbsp;<br><strong>Documents:<\/strong> CSR, Summary of Clinical Safety, Summary of Clinical Efficacy&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-7 kt-pane26_45d096-ac\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">5. Manufacturing Readiness<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Drug-device combination compliance strategy (e.g., CFR 4)&nbsp;<\/li>\n\n\n\n<li>EMA\/Notified Body consultation&nbsp;<br><strong>Documents:<\/strong> Manufacturing SOPs (support), bridging justifications&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Process validation documentation (support only)&nbsp;<\/li>\n\n\n\n<li>Final DMR\/DHF review&nbsp;<br><strong>Documents:<\/strong> Validation plan (documentation support), lot release SOPs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Finalize IFU and training materials for HCPs&nbsp;<br><strong>Documents:<\/strong> Training plan, clinical performance checklist&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Payer-facing clinical utility justification&nbsp;<br><strong>Documents:<\/strong> Updated economic model or HTA pre-submission package&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Final E&amp;L, stability, shelf-life support&nbsp;<br><strong>Documents:<\/strong> Final test reports&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Final IFU\/label content&nbsp;<\/li>\n\n\n\n<li>Manufacturing\/administration documentation for submission&nbsp;<br><strong>Documents:<\/strong> Administration guide, packaging insert&nbsp;&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><style>.kt-accordion-id26_6a53a5-63 .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:0px;padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id26_6a53a5-63 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;border-top-right-radius:40px;border-bottom-right-radius:40px;border-bottom-left-radius:40px;background:#fff;font-size:30px;text-transform:none;color:#062464;padding-top:40px;padding-right:32px;padding-bottom:40px;padding-left:32px;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner, .kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner h1, .kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner h2, .kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner h3, .kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner h4, .kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner h5, .kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner h6{color:#062464;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#062464;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_6a53a5-63:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id26_6a53a5-63 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 1024px){.kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 767px){.kt-accordion-id26_6a53a5-63 .kt-accordion-inner-wrap{display:block;}.kt-accordion-id26_6a53a5-63 .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id26_6a53a5-63 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id26_6a53a5-63 .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_6a53a5-63 .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id26_6a53a5-63 kt-accordion-has-7-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane26_52ca96-39\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">6. Regulatory Submissions<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Submission compilation and formatting (eCTD, 510(k), PMA, BLA\/IND)&nbsp;<\/li>\n\n\n\n<li>Drug-device combination modules (Module 3, Annex I per MDR)&nbsp;<\/li>\n\n\n\n<li>Responses to FDA\/EMA\/NB queries&nbsp;<br><strong>Documents:<\/strong> Full regulatory submission, RTA checklists, deficiency responses&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Audit readiness support&nbsp;<br><strong>Documents:<\/strong> Audit response documents&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Clinical evaluation report (CER)&nbsp;<\/li>\n\n\n\n<li>Clinical summaries (EU and US)&nbsp;<br><strong>Documents:<\/strong> CER, SSCP&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Health economics inclusion in submission (optional)&nbsp;<br><strong>Documents:<\/strong> HTA-ready value dossier sections&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Inclusion of full chemistry and toxicology package&nbsp;<br><strong>Documents:<\/strong> Chemical characterization summaries&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Compilation of technical documents&nbsp;<\/li>\n\n\n\n<li>Regulatory writing support for submission documents&nbsp;<br><strong>Documents:<\/strong> Clinical Overview, 2.7.1\u20132.7.4 summaries&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-4 kt-pane26_e891e7-18\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">7. Market Access &amp; Launch<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Global registrations&nbsp;<\/li>\n\n\n\n<li>Labeling translation review (EU)&nbsp;<br><strong>Documents:<\/strong> Registration forms, packaging content&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Post-market surveillance planning&nbsp;<\/li>\n\n\n\n<li>Product complaint system setup&nbsp;<br><strong>Documents:<\/strong> PMS plan, complaint handling SOPs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>PMCF plan&nbsp;<\/li>\n\n\n\n<li>Registry planning&nbsp;<br><strong>Documents:<\/strong> PMCF plan, RWD study framework&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Coding assignment (US: HCPCS, EU: NUB)&nbsp;<\/li>\n\n\n\n<li>Payer engagement&nbsp;<br><strong>Documents:<\/strong> Coding request letters, coverage justifications&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Ongoing batch testing&nbsp;<\/li>\n\n\n\n<li>Real-time aging studies&nbsp;<br><strong>Documents:<\/strong> Batch test reports&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>PMCF study documents&nbsp;<\/li>\n\n\n\n<li>Payer communication tools&nbsp;<br><strong>Documents:<\/strong> PMCF protocols, evidence summaries&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane26_805c41-c3\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">8. Post-Market Activities<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Vigilance support&nbsp;<\/li>\n\n\n\n<li>Periodic safety update reports (PSUR)&nbsp;<br><strong>Documents:<\/strong> PSUR, MDRs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>CAPA system setup and oversight&nbsp;<\/li>\n\n\n\n<li>Periodic audit support&nbsp;<br><strong>Documents:<\/strong> CAPA reports, internal audit plans&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>PMCF surveys and studies&nbsp;<br><strong>Documents:<\/strong> PMCF reports, clinical update summaries&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>HTA reassessment submissions&nbsp;<br><strong>Documents:<\/strong> Updated value dossiers&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Long-term stability and impurity profiling&nbsp;<br><strong>Documents:<\/strong> Updated test reports&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Safety summary reports&nbsp;<\/li>\n\n\n\n<li>PMS-related narrative reports&nbsp;<br><strong>Documents:<\/strong> PSUR narrative, PMS summary&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane26_6b1f4c-5a\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">9. Design Changes, M&amp;A, &amp; Market Expansion<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Change impact assessments&nbsp;<\/li>\n\n\n\n<li>Global change notification support&nbsp;<br><strong>Documents:<\/strong> Supplement submissions, change memos&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Change control documentation&nbsp;<\/li>\n\n\n\n<li>QMS integration planning (post-M&amp;A)&nbsp;<br><strong>Documents:<\/strong> Updated SOPs, integration plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Bridging studies and labeling extensions&nbsp;<br><strong>Documents:<\/strong> Bridging protocol, justification memo&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Pricing update strategy&nbsp;<br><strong>Documents:<\/strong> Payer re-engagement materials&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>New formulation testing&nbsp;<\/li>\n\n\n\n<li>Comparative testing&nbsp;<br><strong>Documents:<\/strong> Side-by-side chemical assessments&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Update IFU, CERs, and submission modules&nbsp;<br><strong>Documents:<\/strong> Revised CER, Summary of Product Characteristics&nbsp;&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-7 kt-pane26_5c66b0-58\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">10. Emergency Support<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li><strong>Regulatory<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Regulatory remediation (warning letter, CE mark suspension)&nbsp;<\/li>\n\n\n\n<li>Emergency meeting request drafting and response strategy&nbsp;<br><strong>Documents:<\/strong> Remediation plans, briefing docs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>CAPA plans under regulatory scrutiny&nbsp;<\/li>\n\n\n\n<li>QMS overhaul under tight timelines&nbsp;<br><strong>Documents:<\/strong> CAPA logs, QMS revision memos&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Safety incident investigation&nbsp;<\/li>\n\n\n\n<li>Emergency PMCF implementation&nbsp;<br><strong>Documents:<\/strong> Safety reports, rapid evidence summaries&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Payer renegotiation following adverse events&nbsp;<br><strong>Documents:<\/strong> Risk mitigation plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs (Jordi Labs)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Confirmatory testing under urgent conditions&nbsp;<br><strong>Documents:<\/strong> Emergency test summary&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Root cause analysis documents&nbsp;<\/li>\n\n\n\n<li>Urgent regulatory communications&nbsp;<br><strong>Documents:<\/strong> Safety notices, response narratives&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\"><\/div>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-bottom:0px\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-8f64e65c38af33cb8cd6d137aab5f45f\"><strong>Partner Testimonial<\/strong><\/h2>\n\n\n<div id=\"slider-block_65643a9230b00e432d442efbbf349ead\" class=\"block-slider\">\n\n    <div class=\"sc-block-carousel\" data-slick='{\"arrows\": true, \"dots\": true, \"autoplay\": true}'>\n        \n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cI have been working with RQM+ for the last couple of years. They have always been systematic and thorough in getting the documents completed on time. Very approachable to have any discussions or clarifications on the EU MDR process. Working with RQM+ has been a great experience.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Clinical Development Specialist, Global Medical Device Manufacturer<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\">\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-text-align-center\"><em>\u201cThe teams worked great together to successfully deliver the Periodic Safety Update Report on time with no rework or change authorizations needed.\u201d<\/em><\/p>\n\n\n\n<p class=\"has-text-align-center has-medium-font-size\">Post-Market Quality Assurance Specialist, Innovative MedTech Company<\/p>\n<\/blockquote>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n<div id=\"rqm-group-block_96f018dcc8aa25d6a893ec422a42daac\" class=\"block-rqm-group alignfull has-background has-light-gray-background-color\" style=\"background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-left.avif');background-position: left top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n\n<h2 class=\"wp-block-heading has-text-align-center has-pink-color has-text-color has-link-color wp-elements-14f54eaa64a47ff1427e944d68d73e26\"><strong>Combination Products FAQs<\/strong><\/h2>\n\n\n<style>.kt-accordion-id26_ced31d-de .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id26_ced31d-de .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-md, 2rem);padding-right:var(--global-kb-spacing-xl, 4rem);padding-bottom:var(--global-kb-spacing-md, 2rem);padding-left:var(--global-kb-spacing-xl, 4rem);}.kt-accordion-id26_ced31d-de .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;border-top-right-radius:40px;border-bottom-right-radius:40px;border-bottom-left-radius:40px;background:#fff;font-size:30px;line-height:1.25;text-transform:none;color:#062464;padding-top:40px;padding-right:32px;padding-bottom:40px;padding-left:32px;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id26_ced31d-de .kt-accordion-panel-inner, .kt-accordion-id26_ced31d-de .kt-accordion-panel-inner h1, .kt-accordion-id26_ced31d-de .kt-accordion-panel-inner h2, .kt-accordion-id26_ced31d-de .kt-accordion-panel-inner h3, .kt-accordion-id26_ced31d-de .kt-accordion-panel-inner h4, .kt-accordion-id26_ced31d-de .kt-accordion-panel-inner h5, .kt-accordion-id26_ced31d-de .kt-accordion-panel-inner h6{color:#062464;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#062464;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#062464;}.kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{color:#fff;background:#062464;border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#fff;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#fff;}.kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id26_ced31d-de:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#062464;}@media all and (max-width: 1024px){.kt-accordion-id26_ced31d-de .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id26_ced31d-de .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:30px;padding-top:32px;padding-bottom:32px;}}@media all and (max-width: 1024px){.kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 1024px){.kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}@media all and (max-width: 767px){.kt-accordion-id26_ced31d-de .kt-accordion-inner-wrap{display:block;}.kt-accordion-id26_ced31d-de .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id26_ced31d-de .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id26_ced31d-de .wp-block-kadence-pane .kt-accordion-header-wrap .kt-blocks-accordion-header{border-top:4px solid #ff4ca5;border-right:4px solid #ff4ca5;border-bottom:4px solid #ff4ca5;border-left:4px solid #ff4ca5;font-size:20px;padding-top:28px;padding-bottom:28px;}.kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id26_ced31d-de .kt-accordion-header-wrap .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:4px solid #062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id26_ced31d-de kt-accordion-has-6-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-arrow kt-accodion-icon-side-right\" style=\"max-width:1012px\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane26_f00676-31\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong>What is the impact of adding a recognized drug to my device?<\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">In the U.S., under the 510(k) process, it can be fairly straightforward on the submission side if you have a predicate that utilizes the same drug product at the same level. Adding an established drug that hasn\u2019t been used in a device complicates the situation tremendously. It most likely will raise new questions of safety and performance leading to a de novo or PMA pathway. Adding a new chemical entity that functions as a drug will bring a consult from CDER on your device submission and all the testing to support the product just like a New Drug Application (NDA). In the EU, the answer is that if the drug is ancillary to the device, you will leap all the way to a Class III device under Rule 14 and the drug substance dossier will be reviewed in addition to your full technical documentation package at the NB. Entering into the combination product world also means you will have to follow additional quality system regulations including 21 CFR 4 in the U.S.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane26_e8adbc-87\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong>I\u2019m developing a combination product \u2014 do I need to submit a drug and a device application?<\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">While some combination products can rely on a single application to gain regulatory approval, the simple answer is this \u2014 it depends! There are two main factors that impact this decision:<\/p>\n\n\n\n<ul class=\"wp-block-list has-body-font-size\">\n<li>The intended market \u2014 U.S. and EU have key differences<\/li>\n\n\n\n<li>The type of combination product \u2014 There are regulatory differences for single-entity\/integral products, co-packaged products, or cross-labeled products<\/li>\n<\/ul>\n\n\n\n<p class=\"has-body-font-size\">In the U.S., combination products that are single-entity or co-packaged products are assigned to a single FDA Center that will have primary jurisdiction for its premarket review and regulation based on the most important therapeutic action. Typically, only a single marketing application is necessary for these types of combination products although inter-agency consults may be utilized during the review of the application. In an example where the most important therapeutic action is the drug, then the product will require a drug application and will be regulated by CDER. During the drug application review, a consult with CDRH may be requested for the device constituent of the product. Conversely, if the most important therapeutic action is the device, then the product will require a device submission to CDRH and may include a CDER consult during the review. Products where the drug and the device constituents would be sold separately and labeled to be used together are considered cross-labeled combination products. For these products, each constituent would typically be regulated separately, and each product would require their own marketing applications to the appropriate FDA Centers.<\/p>\n\n\n\n<p class=\"has-body-font-size\">In the EU, Article 117 of the new EU MDR introduced new requirements for drugs with an integral medical device, which are equivalent to single-entity products in the U.S. Since 2021 the drug application will need to include a CE certificate for the device or include an opinion from a notified body on the conformity of the device if it is not CE marked. The notified body opinion could be obtained during the drug review if it is not separately CE marked. Devices with an integral medicinal product are automatically classified as Class III medical devices and may require a drug review to achieve CE marking. Co-packaged products are treated differently in the EU and would typically require separate device and drug applications. Cross-labeled products align with the U.S. in that CE marking is required separately from the drug application for these product types.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane26_93ff1f-28\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Should I use the Pre-Request for Designation (Pre-RFD) process or the Request for Designation (RFD) process to determine what will be the lead FDA Center assigned to review my product?<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">The Pre-RFD process is used to get informal and non-binding feedback from the FDA about your combination product, whereas the RFD process provides binding feedback through a formal process. The Pre-RFD is helpful early in the product development stages where you may want to understand how the agency is likely to designate the lead center for reviewing your combination product \u2014 CDER, CBER, or CDRH. The Pre-RFD process provides a flexible and approachable way to obtain informal feedback from the Agency about the type of marketing application and the lead FDA Center that is most likely to be assigned for review and regulation of the product. If you are in later stages of development and the device does not have a clear primary mode of action, then the formal RFD process provides a binding decision to assign the lead center for review. This process can be used to avoid rejection or delays in a marketing application if the classification or assignment is determined to be unclear or in dispute during the review process. It is important to note that a Pre-RFD or an RFD are not always required for a product. If the product is very similar to an existing product, then it is possible to rely on capsular decisions that are posted on the FDA website to understand how similar products have been assigned.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane26_fedc4a-76\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong><strong>I have a legacy drug product that is considered a combination product in the U.S. Do I need to make any changes to my quality system to ensure I\u2019m meeting the combination product regulations?<\/strong><\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"has-body-font-size\">Yes, your drug quality system will need to be adjusted to comply with additional device quality system requirements under 21 CFR 820 for management responsibility, design controls, purchasing controls, corrective and preventive action, installation, and servicing. While many of these elements may be covered in Pharmaceutical Quality Systems, design controls is one element that typically poses the most significant challenge for drug manufacturers. Design controls are a systematic process to ensure the product design meets the user needs, the intended uses, and any specific regulatory requirements. The design process culminates in a design history file, or a DHF, that is maintained over the product lifecycle. Drug manufacturers often need to adjust their quality systems to meet these requirements and also perform DHF remediation to ensure that changes in the product are appropriately documented over the lifecycle.<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n\n\n    <\/div>\n\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Combination products represent the forefront of innovation, merging the best of drug, biologic, and device technologies to revolutionize patient care&#8230;.<\/p>\n","protected":false},"author":2,"featured_media":977,"parent":38,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-26","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"card_info":{"title":"Combination Products","link":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/","link_target":"_self","name":"Page","slug":"page","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg","excerpt":"Combination products represent the forefront of innovation, merging the best of drug, biologic, and device technologies to revolutionize patient care....","display_date":"January 8, 2025"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Combination Products | Regulatory Expertise<\/title>\n<meta name=\"description\" content=\"Navigate medical device combination product regulations with expert guidance and integrated solutions. Let RQM+ support you.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Combination Products | Regulatory Expertise\" \/>\n<meta property=\"og:description\" content=\"Navigate medical device combination product regulations with expert guidance and integrated solutions. Let RQM+ support you.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\" \/>\n<meta property=\"og:site_name\" content=\"RQM+\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RQMplus\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-19T18:06:55+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1800\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@RQMplus\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"11 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\",\"url\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\",\"name\":\"Medical Device Combination Products | Regulatory Expertise\",\"isPartOf\":{\"@id\":\"https:\/\/www.rqmplus.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg\",\"datePublished\":\"2025-01-08T12:20:50+00:00\",\"dateModified\":\"2025-09-19T18:06:55+00:00\",\"description\":\"Navigate medical device combination product regulations with expert guidance and integrated solutions. Let RQM+ support you.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#primaryimage\",\"url\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg\",\"contentUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg\",\"width\":1800,\"height\":1200,\"caption\":\"Two professionally dressed women reviewing something on a tablet while standing in a glass-walled office hallway.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Expertise\",\"item\":\"https:\/\/www.rqmplus.com\/expertise\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Combination Products\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rqmplus.com\/#website\",\"url\":\"https:\/\/www.rqmplus.com\/\",\"name\":\"RQM+\",\"description\":\"Evolving MedTech\",\"publisher\":{\"@id\":\"https:\/\/www.rqmplus.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rqmplus.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.rqmplus.com\/#organization\",\"name\":\"RQM+\",\"url\":\"https:\/\/www.rqmplus.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png\",\"contentUrl\":\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png\",\"width\":696,\"height\":696,\"caption\":\"RQM+\"},\"image\":{\"@id\":\"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/RQMplus\",\"https:\/\/x.com\/RQMplus\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Medical Device Combination Products | Regulatory Expertise","description":"Navigate medical device combination product regulations with expert guidance and integrated solutions. Let RQM+ support you.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/","og_locale":"en_US","og_type":"article","og_title":"Medical Device Combination Products | Regulatory Expertise","og_description":"Navigate medical device combination product regulations with expert guidance and integrated solutions. Let RQM+ support you.","og_url":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/","og_site_name":"RQM+","article_publisher":"https:\/\/www.facebook.com\/RQMplus","article_modified_time":"2025-09-19T18:06:55+00:00","og_image":[{"width":1800,"height":1200,"url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_site":"@RQMplus","twitter_misc":{"Est. reading time":"11 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/","url":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/","name":"Medical Device Combination Products | Regulatory Expertise","isPartOf":{"@id":"https:\/\/www.rqmplus.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#primaryimage"},"image":{"@id":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#primaryimage"},"thumbnailUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg","datePublished":"2025-01-08T12:20:50+00:00","dateModified":"2025-09-19T18:06:55+00:00","description":"Navigate medical device combination product regulations with expert guidance and integrated solutions. Let RQM+ support you.","breadcrumb":{"@id":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rqmplus.com\/expertise\/combination-products\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#primaryimage","url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg","contentUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/women-looking-at-tablet.jpg","width":1800,"height":1200,"caption":"Two professionally dressed women reviewing something on a tablet while standing in a glass-walled office hallway."},{"@type":"BreadcrumbList","@id":"https:\/\/www.rqmplus.com\/expertise\/combination-products\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Expertise","item":"https:\/\/www.rqmplus.com\/expertise\/"},{"@type":"ListItem","position":2,"name":"Combination Products"}]},{"@type":"WebSite","@id":"https:\/\/www.rqmplus.com\/#website","url":"https:\/\/www.rqmplus.com\/","name":"RQM+","description":"Evolving MedTech","publisher":{"@id":"https:\/\/www.rqmplus.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rqmplus.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.rqmplus.com\/#organization","name":"RQM+","url":"https:\/\/www.rqmplus.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png","contentUrl":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/logo.png","width":696,"height":696,"caption":"RQM+"},"image":{"@id":"https:\/\/www.rqmplus.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RQMplus","https:\/\/x.com\/RQMplus"]}]}},"_links":{"self":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages\/26","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/comments?post=26"}],"version-history":[{"count":0,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages\/26\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/pages\/38"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/media\/977"}],"wp:attachment":[{"href":"https:\/\/www.rqmplus.com\/wp-json\/wp\/v2\/media?parent=26"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}