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Support<\/strong><\/h2>\n\n  \n    <\/div>\n<\/div>\n\n\n\n<p>At RQM+, we go beyond standard regulatory frameworks to ensure your product is compliant across all critical global regulations. We cover:&nbsp;<\/p>\n\n\n<div id=\"rqm-list-block_d10dad03954fd3241a7172f6af86c80d\" class=\"block-rqm-list\">\n\n    <ul class=\"rqm-list\">\n        \n<li id=\"rqm-list-item-block_f3904d3725a682272f1fbafcfe408b0f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Regulatory Essentials<\/h3>\n\n\n\n<p>QMSR, EU MDR, IVDR, and ISO 13485<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_f3904d3725a682272f1fbafcfe408b0f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Artificial Intelligence Act<\/h3>\n\n\n\n<p>Compliance for AI-driven medical technologies<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_f3904d3725a682272f1fbafcfe408b0f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)<\/h3>\n\n\n\n<p>Ensuring product safety and environmental sustainability<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_f3904d3725a682272f1fbafcfe408b0f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Battery Regulation<\/h3>\n\n\n\n<p>Supporting MedTech devices with integrated battery systems<\/p>\n\n       \n<\/li>\n\n\n<li id=\"rqm-list-item-block_f3904d3725a682272f1fbafcfe408b0f\" class=\"block-rqm-list-item\">\n    \n\n<h3 class=\"wp-block-heading\">Packaging and Packaging Waste Regulation (PPWR)<\/h3>\n\n\n\n<p>Sustainable packaging compliance for global markets<\/p>\n\n       \n<\/li>\n\n\n    <\/ul>\n\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n<section id=\"content-list-block_9bafc19bc2039137c8cb09d580730ed3\" class=\"block-content-list alignwide has-image\">\n    \n    <style>\n                #content-list-block_9bafc19bc2039137c8cb09d580730ed3 .clb-image {\n            background: url(https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/doctor-with-patient-1.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-40f1434c02bf73608eb689c9ca4abe96\"><strong><strong><strong><strong>Key New Product Development Benefits<\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p class=\"white-text\">When you collaborate with RQM+, you receive benefits that directly impact your product\u2019s success and improve patient outcomes:&nbsp;<\/p>\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_9bafc19bc2039137c8cb09d580730ed3-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\/stopwatch.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Reduce Rework and Delays<\/h3>\n                                            <p class=\"list-text\">Many 510(k) submissions are rejected at the Refuse to Accept (RTA) stage due to avoidable errors (e.g., incomplete documentation or improper formatting). Our experts have supported hundreds of successful FDA and EU submissions. <em>We help you get it right the first time<\/em>.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9bafc19bc2039137c8cb09d580730ed3-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\/playbook.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Navigate EU MDR and IVDR<\/h3>\n                                            <p class=\"list-text\">Notified body survey found that only ~25% of notified bodies considered initial EU MDR submissions complete. This can lead to prolonged review timelines of 18 months or more. Our former regulators and notified body reviewers ensure your submission is complete, clear, and aligned with expectations.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9bafc19bc2039137c8cb09d580730ed3-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\/checkboard-checkmark.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Regulatory Expertise<\/h3>\n                                            <p class=\"list-text\">Our team includes former FDA reviewers, notified body leaders, and global regulatory consultants who understand the nuances of international market requirements. <em>We help you anticipate challenges before they happen<\/em>.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_9bafc19bc2039137c8cb09d580730ed3-row-3\" 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\/scalable.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Scalable Support for Any MedTech Company<\/h3>\n                                            <p class=\"list-text\">Whether you\u2019re <a href=\"\/emerging-medtech-companies\/\">a startup bringing your first device to market<\/a> or a global MedTech leader expanding into new regions, we tailor our regulatory, clinical, and reimbursement strategies to your product. <\/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_b6e4a34daf47c3592c9c13d931bc84b2\" 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 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-1897f47fc43ac275c932dbdd7aa836cf\"><strong><strong><strong>Core Medical Device Development Consulting Services<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>We provide comprehensive services tailored to ensure your product\u2019s success, including:&nbsp;<\/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-id41_022452-f6 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.kt-accordion-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id41_022452-f6 .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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6: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-id41_022452-f6 .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-id41_022452-f6 .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-id41_022452-f6 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id41_022452-f6 .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-id41_022452-f6 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id41_022452-f6 .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-id41_022452-f6 .kt-accordion-inner-wrap{display:block;}.kt-accordion-id41_022452-f6 .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id41_022452-f6 .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-id41_022452-f6 .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-id41_022452-f6 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id41_022452-f6 .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-id41_022452-f6 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id41_022452-f6 .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-id41_022452-f6 kt-accordion-has-5-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-pane41_a73965-79\"><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\">Regulatory Strategy &amp; Submissions&nbsp;<\/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>FDA submissions:&nbsp;&nbsp;\n<ul class=\"wp-block-list\">\n<li>510(k) Premarket Notifications&nbsp;<\/li>\n\n\n\n<li>De Novo Applications&nbsp;<\/li>\n\n\n\n<li>Premarket Approvals (PMAs)&nbsp;<\/li>\n\n\n\n<li>Emergency Use Authorization (EUA)&nbsp;<\/li>\n\n\n\n<li>Request for Designations (RFDs)&nbsp;<\/li>\n\n\n\n<li>Pre-Submission (Q-Sub)&nbsp;<\/li>\n\n\n\n<li>Investigational Device Exemptions (IDEs)&nbsp;&nbsp;<\/li>\n\n\n\n<li>Breakthrough Designation Requests&nbsp;<\/li>\n\n\n\n<li>Humanitarian Use Device (HUD)&nbsp;<\/li>\n\n\n\n<li>Safer Technologies Program (SteP)&nbsp;&nbsp;<\/li>\n\n\n\n<li>Request for Information (513(g))&nbsp;<\/li>\n\n\n\n<li>Drug-Device Combination Products (IND, NDA, ANDA, BLA \u2013 Device portion only)&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>CE marking and MDR\/IVDR compliance&nbsp;<\/li>\n\n\n\n<li>Regulatory pathway analysis and strategic planning&nbsp;\n<ul class=\"wp-block-list\">\n<li>Worldwide regulatory strategies&nbsp;<\/li>\n\n\n\n<li>Submission review (U.S. or EU)&nbsp;<\/li>\n\n\n\n<li>Refuse to accept or hold letter support&nbsp;<\/li>\n\n\n\n<li>Acquisition due diligence review&nbsp;<\/li>\n\n\n\n<li>Biological evaluation plans\/reports&nbsp;<\/li>\n\n\n\n<li>Change impact assessments&nbsp;<\/li>\n\n\n\n<li>Marketing and labeling review&nbsp;<\/li>\n\n\n\n<li>Registrations and listings&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Reimbursement strategies and approvals&nbsp;<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane41_0e97e3-25\"><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\">Design Assurance &amp; Technical Documentation Support&nbsp;<\/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>Development of Design History Files (DHF) and technical documentation&nbsp;<\/li>\n\n\n\n<li>Risk management plans and safety analyses&nbsp;<\/li>\n\n\n\n<li>Verification\/validation (V&amp;V) support&nbsp;<\/li>\n\n\n\n<li>Manufacturing and supplier quality&nbsp;<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane41_8fe61c-88\"><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\">Global Market Navigation<\/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>Expertise in U.S., EU, U.K., Canadian, and APAC regulatory frameworks&nbsp;<\/li>\n\n\n\n<li>Integrated support for combination products and IVDs&nbsp;<\/li>\n\n\n\n<li>Ongoing collaboration with notified bodies in the EU and the FDA in the U.S.&nbsp;<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n\n\n\n<div 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):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-id41_632dc8-82 .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-id41_632dc8-82 .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-id41_632dc8-82 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id41_632dc8-82 .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-id41_632dc8-82 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id41_632dc8-82 .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-id41_632dc8-82 .kt-accordion-inner-wrap{display:block;}.kt-accordion-id41_632dc8-82 .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id41_632dc8-82 .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-id41_632dc8-82 .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-id41_632dc8-82 .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id41_632dc8-82 .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-id41_632dc8-82 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id41_632dc8-82 .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-id41_632dc8-82 kt-accordion-has-5-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-4 kt-pane41_dad0aa-7a\"><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\">Quality Management System (Support)&nbsp;<\/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>QMS development&nbsp;<\/li>\n\n\n\n<li>QMS audits&nbsp;<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane41_83119e-3a\"><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\">Clinical Trial 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>Literature searches and clinical strategy&nbsp;<\/li>\n\n\n\n<li>Clinical investigation plans\/protocols&nbsp;<\/li>\n\n\n\n<li>Draft study documents&nbsp;<\/li>\n\n\n\n<li>Clinical study approval&nbsp;<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group has-body-font-size is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px;padding-bottom:0px\">\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><section id=\"decorative-image-block_6139073cd96c06413fc426ae9af3b0b1\" class=\"block-decorative-image\">\n    <div class=\"decorative-image-container\">\n        <div class=\"decorative-image-background\" style=\"background-color: #ff4ca5; width: 400px;\">\n            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/woman-shaking-hand.jpg\" width=\"400\" height=\"400\"  alt=\"\" \/>\n        <\/div>\n    <\/div>\n<\/section>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\"><strong>History of Success<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list has-body-font-size\">\n<li>Supported 19 of the top 20 medical device manufacturers&nbsp;<\/li>\n\n\n\n<li>Over 40 years of regulatory consulting expertise&nbsp;<\/li>\n\n\n\n<li>Proven success navigating U.S., EU, and U.K. regulatory landscapes&nbsp;<\/li>\n\n\n\n<li>Recognized as leaders in design assurance and risk management<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n<div id=\"rqm-group-block_31b42020ff58fa61a10401fcefe9a50f\" class=\"block-rqm-group alignfull has-background has-light-gray-background-color\" style=\"padding-bottom: 0px; background-image: url('https:\/\/www.rqmplus.com\/wp-content\/themes\/rqm-2025\/img\/bg-right.avif');background-position: right top -30em;\">\n\n    <div class=\"rqm-group-content\">\n        \n\n<h2 class=\"wp-block-heading\"><strong><strong>Device-Specific Expertise<\/strong><\/strong><\/h2>\n\n\n\n<p>Looking for tailored solutions for your specific product type? Explore our dedicated pages for:&nbsp;<\/p>\n\n\n\n<div class=\"wp-block-group alignwide is-layout-constrained wp-block-group-is-layout-constrained\" style=\"padding-top:0px\">\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<style>\n            a#card-icon-link-block-block_81656df30129fada2bdf12fe316ffd8d:hover, a#card-icon-link-block-block_81656df30129fada2bdf12fe316ffd8d:focus, a#card-icon-link-block-block_81656df30129fada2bdf12fe316ffd8d:focus-visible {\n        background: #e87722 !important;\n    }\n    <\/style>\n\n<section id=\"icon-link-block-block_81656df30129fada2bdf12fe316ffd8d\" class=\"block-iconlink card-style-icon has-color-e87722\">\n    \n    \n        <a class=\"icon-link icon-link-large\" id=\"card-icon-link-block-block_81656df30129fada2bdf12fe316ffd8d\" href=\"https:\/\/www.rqmplus.com\/expertise\/med-device\/\" aria-label=\"Medical Devices\" >\n                            <div class=\"fs-icon\">\n                    <div class=\"fs-icon-outer\" style=\"border: .3em solid #e87722;\">\n                        <div class=\"fs-icon-image icon-echo\">\n                            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/med-device.svg\" alt=\"\" width=\"82\" height=\"82\" \/>\n                        <\/div>\n                    <\/div>\n                <\/div>\n                \n            <div class=\"fs-content-container\">\n                <p class=\"fs-title\">Medical Devices<\/p>\n                                <p class=\"fs-cta\">\n                    <svg class=\"pink-circle\" viewBox=\"0 0 157.33 157.33\" width=\"30\" height=\"30\" aria-hidden=\"true\" fill=\"#fff\">\n                        <rect x=\"46.78\" y=\"49.91\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(64.76 -41.7) rotate(45)\"><\/rect>\n                        <rect x=\"46.78\" y=\"90.28\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(-44.85 87.1) rotate(-45)\"><\/rect>\n                    <\/svg>\n                    <span class=\"cta-text\">Continue to Medical Device<\/span>\n                <\/p>\n            <\/div>\n        <\/a>\n        \n    \n    \n<\/section>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<style>\n            a#card-icon-link-block-block_9cf759ac5e4cc674ab3727073dfe7090:hover, a#card-icon-link-block-block_9cf759ac5e4cc674ab3727073dfe7090:focus, a#card-icon-link-block-block_9cf759ac5e4cc674ab3727073dfe7090:focus-visible {\n        background: #c6dd63 !important;\n    }\n    <\/style>\n\n<section id=\"icon-link-block-block_9cf759ac5e4cc674ab3727073dfe7090\" class=\"block-iconlink card-style-icon has-color-c6dd63\">\n    \n    \n        <a class=\"icon-link icon-link-large\" id=\"card-icon-link-block-block_9cf759ac5e4cc674ab3727073dfe7090\" href=\"https:\/\/www.rqmplus.com\/expertise\/ivd\/\" aria-label=\"In Vitro Diagnostics\u00a0\" >\n                            <div class=\"fs-icon\">\n                    <div class=\"fs-icon-outer\" style=\"border: .3em solid #c6dd63;\">\n                        <div class=\"fs-icon-image icon-echo\">\n                            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/test-tube-circle.svg\" alt=\"\" width=\"82\" height=\"82\" \/>\n                        <\/div>\n                    <\/div>\n                <\/div>\n                \n            <div class=\"fs-content-container\">\n                <p class=\"fs-title\">In Vitro Diagnostics\u00a0<\/p>\n                                <p class=\"fs-cta\">\n                    <svg class=\"pink-circle\" viewBox=\"0 0 157.33 157.33\" width=\"30\" height=\"30\" aria-hidden=\"true\" fill=\"#fff\">\n                        <rect x=\"46.78\" y=\"49.91\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(64.76 -41.7) rotate(45)\"><\/rect>\n                        <rect x=\"46.78\" y=\"90.28\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(-44.85 87.1) rotate(-45)\"><\/rect>\n                    <\/svg>\n                    <span class=\"cta-text\">Continue to In Vitro Diagnostics<\/span>\n                <\/p>\n            <\/div>\n        <\/a>\n        \n    \n    \n<\/section>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8eafb21d wp-block-columns-is-layout-flex\" style=\"margin-top:0px\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<style>\n            a#card-icon-link-block-block_46ead331cf0c69046a233baa505c5f5b:hover, a#card-icon-link-block-block_46ead331cf0c69046a233baa505c5f5b:focus, a#card-icon-link-block-block_46ead331cf0c69046a233baa505c5f5b:focus-visible {\n        background: #84cec3 !important;\n    }\n    <\/style>\n\n<section id=\"icon-link-block-block_46ead331cf0c69046a233baa505c5f5b\" class=\"block-iconlink card-style-icon has-color-84cec3\">\n    \n    \n        <a class=\"icon-link icon-link-large\" id=\"card-icon-link-block-block_46ead331cf0c69046a233baa505c5f5b\" href=\"https:\/\/www.rqmplus.com\/expertise\/combination-products\/\" aria-label=\"Combination Products\" >\n                            <div class=\"fs-icon\">\n                    <div class=\"fs-icon-outer\" style=\"border: .3em solid #84cec3;\">\n                        <div class=\"fs-icon-image icon-echo\">\n                            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/RQM-Icon-White-Outline_48.svg\" alt=\"\" width=\"82\" height=\"82\" \/>\n                        <\/div>\n                    <\/div>\n                <\/div>\n                \n            <div class=\"fs-content-container\">\n                <p class=\"fs-title\">Combination Products<\/p>\n                                <p class=\"fs-cta\">\n                    <svg class=\"pink-circle\" viewBox=\"0 0 157.33 157.33\" width=\"30\" height=\"30\" aria-hidden=\"true\" fill=\"#fff\">\n                        <rect x=\"46.78\" y=\"49.91\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(64.76 -41.7) rotate(45)\"><\/rect>\n                        <rect x=\"46.78\" y=\"90.28\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(-44.85 87.1) rotate(-45)\"><\/rect>\n                    <\/svg>\n                    <span class=\"cta-text\">Continue to Combination Products<\/span>\n                <\/p>\n            <\/div>\n        <\/a>\n        \n    \n    \n<\/section>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<style>\n            a#card-icon-link-block-block_60c9e566dbf4c9a2d2f1a32078e1a956:hover, a#card-icon-link-block-block_60c9e566dbf4c9a2d2f1a32078e1a956:focus, a#card-icon-link-block-block_60c9e566dbf4c9a2d2f1a32078e1a956:focus-visible {\n        background: #ff4ca5 !important;\n    }\n    <\/style>\n\n<section id=\"icon-link-block-block_60c9e566dbf4c9a2d2f1a32078e1a956\" class=\"block-iconlink card-style-icon has-color-ff4ca5\">\n    \n    \n        <a class=\"icon-link icon-link-large\" id=\"card-icon-link-block-block_60c9e566dbf4c9a2d2f1a32078e1a956\" href=\"https:\/\/www.rqmplus.com\/expertise\/software-enabled-products\/\" aria-label=\"Software-Enabled Products\" >\n                            <div class=\"fs-icon\">\n                    <div class=\"fs-icon-outer\" style=\"border: .3em solid #ff4ca5;\">\n                        <div class=\"fs-icon-image icon-echo\">\n                            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/02\/RQM-Icon-White-Outline_5.svg\" alt=\"\" width=\"82\" height=\"82\" \/>\n                        <\/div>\n                    <\/div>\n                <\/div>\n                \n            <div class=\"fs-content-container\">\n                <p class=\"fs-title\">Software-Enabled Products<\/p>\n                                <p class=\"fs-cta\">\n                    <svg class=\"pink-circle\" viewBox=\"0 0 157.33 157.33\" width=\"30\" height=\"30\" aria-hidden=\"true\" fill=\"#fff\">\n                        <rect x=\"46.78\" y=\"49.91\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(64.76 -41.7) rotate(45)\"><\/rect>\n                        <rect x=\"46.78\" y=\"90.28\" width=\"71.87\" height=\"14.82\" rx=\"7.41\" ry=\"7.41\" transform=\"translate(-44.85 87.1) rotate(-45)\"><\/rect>\n                    <\/svg>\n                    <span class=\"cta-text\">Continue to Software-Enabled Products<\/span>\n                <\/p>\n            <\/div>\n        <\/a>\n        \n    \n    \n<\/section>\n<\/div>\n<\/div>\n<\/div>\n\n\n    <\/div>\n\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-28f84493 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><section id=\"decorative-image-block_b079af395c593a7e6bd7120170c3b79f\" class=\"block-decorative-image\">\n    <div class=\"decorative-image-container\">\n        <div class=\"decorative-image-background\" style=\"background-color: #ff4ca5; width: 400px;\">\n            <img decoding=\"async\" src=\"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/03\/woman-with-oxygen.jpg\" width=\"400\" height=\"400\"  alt=\"\" \/>\n        <\/div>\n    <\/div>\n<\/section>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h3 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-90463840252468ddf4243dbb0a168346\">Therapeutic Area Expertise<\/h3>\n\n\n\n<p class=\"has-body-font-size\">Our expertise extends to numerous therapeutic areas, including:<\/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\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li>Oncology<\/li>\n\n\n\n<li>Respiratory care<\/li>\n\n\n\n<li>General surgery<\/li>\n\n\n\n<li>Women\u2019s health<\/li>\n\n\n\n<li>Infectious disease<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<ul class=\"wp-block-list has-body-font-size\">\n<li>Orthopedics and spine<\/li>\n\n\n\n<li>Urology<\/li>\n\n\n\n<li>Neurology<\/li>\n\n\n\n<li>Wound care<\/li>\n\n\n\n<li>Ophthalmology<\/li>\n<\/ul>\n<\/div>\n<\/div>\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=\"\/expertise\/\">Explore Our Expertise<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>RQM+ is your single stop for IVD, combination product, and medical device development consulting services. 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