{"id":1471,"date":"2025-05-13T08:01:31","date_gmt":"2025-05-13T13:01:31","guid":{"rendered":"https:\/\/www.rqmplus.com\/?page_id=1471"},"modified":"2025-09-19T12:53:52","modified_gmt":"2025-09-19T17:53:52","slug":"software-enabled-products","status":"publish","type":"page","link":"https:\/\/www.rqmplus.com\/expertise\/software-enabled-products\/","title":{"rendered":"Software-Enabled Products"},"content":{"rendered":"<div id=\"rqm-divider-block_c56027f83af9badb1a74ce18921bec74\" 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 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Our expertise <strong>ensures compliance with FDA, EU MDR, and global standards<\/strong>, addressing AI\/ML, cybersecurity, interoperability, and software life cycle management.<\/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_bf49dbac3a6ab48122db5f0823c32e02\" class=\"block-content-list alignwide has-image\">\n    \n    <style>\n                #content-list-block_bf49dbac3a6ab48122db5f0823c32e02 .clb-image {\n            background: url(https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/two-colleagues-collaborating-in-a-modern-office-setting-engaged-in-discussion.-12903143-scaled.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-7c57ba4c0e6c69bd5fc513613a773d46\"><strong><strong><strong><strong>Why RQM+ for Software-Enabled Products?<\/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_bf49dbac3a6ab48122db5f0823c32e02-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\/lightbulb-computer.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Cybersecurity<\/h3>\n                                            <p class=\"list-text\">Compliance with FDA and EU MDR, security risk management, SBOM documentation, and threat mitigation.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_bf49dbac3a6ab48122db5f0823c32e02-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\/data-computer.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Interoperability<\/h3>\n                                            <p class=\"list-text\">Seamless data exchange, regulatory compliance, and alignment with HL7, FHIR, and DICOM.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_bf49dbac3a6ab48122db5f0823c32e02-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\/connected-hexagon.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">AI\/ML<\/h3>\n                                            <p class=\"list-text\">Addressing algorithm bias, model drift, and regulatory approval for adaptive AI systems.<\/p>\n                                        <\/div>\n                                    <\/li>\n    \n                                                                    \n                                        \n                                    <li id=\"content-list-block_bf49dbac3a6ab48122db5f0823c32e02-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\/02\/RQM-Icon-White-Outline_5.svg\" alt=\"\" loading=\"lazy\"\/>\n                                                                                            <\/div>\n                                        <\/div>\n                                        <div class=\"text-container\">\n                                            <h3 class=\"list-header\">Software Development Life Cycle (IEC 62304)<\/h3>\n                                            <p class=\"list-text\">Risk-based classification, validation, version control, and post-market compliance.<\/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\n<div class=\"wp-block-group alignwide is-layout-constrained wp-container-core-group-is-layout-aefc80cc wp-block-group-is-layout-constrained\" style=\"padding-bottom:0px\">\n<div class=\"wp-block-group is-content-justification-center is-nowrap is-layout-flex wp-container-core-group-is-layout-23441af8 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-columns are-vertically-aligned-top 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-top 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-6bc754e45a44fdb7e53886d131013e2d\">Applicable Regulations &amp; Standards<\/h3>\n\n\n\n<div class=\"wp-block-columns are-vertically-aligned-top 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-top is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-text-align-center has-white-color has-blue-background-color has-text-color has-background has-link-color wp-elements-f03a7cfd93bbc10d04f8d9b4865792dd\" style=\"border-radius:32px;padding-top:var(--wp--preset--spacing--20);padding-right:var(--wp--preset--spacing--20);padding-bottom:var(--wp--preset--spacing--20);padding-left:var(--wp--preset--spacing--20)\">United States<\/h4>\n\n\n\n<ul class=\"wp-block-list has-body-font-size\">\n<li>FDA 21 CFR Part 820 \u2013 Quality System Regulation (QSR)<\/li>\n\n\n\n<li>FDA 21 CFR Part 11 \u2013 Electronic Records and Signatures<\/li>\n\n\n\n<li>FDA 510(k), De Novo, PMA \u2013 Regulatory pathways for medical devices<\/li>\n\n\n\n<li>NIST Cybersecurity Framework \u2013 Cybersecurity risk management<\/li>\n\n\n\n<li>IMDRF SaMD Guidance \u2013 Software as a Medical Device classification and compliance<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-text-align-center has-white-color has-blue-background-color has-text-color has-background has-link-color wp-elements-5559faeb002eed2aa89d8dc256c8b6be\" style=\"border-radius:32px;padding-top:var(--wp--preset--spacing--20);padding-right:var(--wp--preset--spacing--20);padding-bottom:var(--wp--preset--spacing--20);padding-left:var(--wp--preset--spacing--20)\">Canada<\/h4>\n\n\n\n<ul class=\"wp-block-list has-body-font-size\">\n<li>Health Canada Medical Device Regulations (SOR\/98-282) \u2013 Regulatory requirements for medical devices<\/li>\n\n\n\n<li>ISO 13485:2016 \u2013 Quality management systems for medical devices<\/li>\n\n\n\n<li>CSA Cybersecurity Standards \u2013 Security compliance for networked medical devices<\/li>\n<\/ul>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\">\n<h4 class=\"wp-block-heading has-text-align-center has-white-color has-blue-background-color has-text-color has-background has-link-color wp-elements-d6559f547c5881f5c39fbb8cd1318e6f\" style=\"border-radius:32px;padding-top:var(--wp--preset--spacing--20);padding-right:var(--wp--preset--spacing--20);padding-bottom:var(--wp--preset--spacing--20);padding-left:var(--wp--preset--spacing--20)\">Europe<\/h4>\n\n\n\n<ul class=\"wp-block-list has-body-font-size\">\n<li>EU MDR (2017\/745) \u2013 Medical Device Regulation for compliance and market access<\/li>\n\n\n\n<li>EU IVDR (2017\/746) \u2013 In Vitro Diagnostic Regulation<\/li>\n\n\n\n<li>ISO 14971 \u2013 Risk management for medical devices<\/li>\n\n\n\n<li>IEC 62304 \u2013 Software lifecycle processes for medical device software<\/li>\n\n\n\n<li>GDPR (General Data Protection Regulation) \u2013 Data privacy and security compliance<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group alignwide is-layout-constrained wp-block-group-is-layout-constrained\" id=\"lifecyclesupport\">\n<h2 class=\"wp-block-heading has-pink-color has-text-color has-link-color wp-elements-6877ebd7ced11a5f120eca16118381e0\"><strong><strong><strong>Integrated Solutions for Software-Enabled Devices<\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p>Expand each to see our 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-id1471_fda402-9a .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id1471_fda402-9a .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-id1471_fda402-9a .wp-block-kadence-pane .kt-accordion-header-wrap 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#062464;border-right:4px solid #062464;border-bottom:4px solid #062464;border-left:4px solid #062464;}.kt-accordion-id1471_fda402-9a: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-id1471_fda402-9a: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-id1471_fda402-9a: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-id1471_fda402-9a: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-id1471_fda402-9a: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-id1471_fda402-9a .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-id1471_fda402-9a .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-id1471_fda402-9a .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1471_fda402-9a .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-id1471_fda402-9a .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1471_fda402-9a .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-id1471_fda402-9a .kt-accordion-inner-wrap{display:block;}.kt-accordion-id1471_fda402-9a .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id1471_fda402-9a .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-id1471_fda402-9a .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-id1471_fda402-9a .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1471_fda402-9a .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-id1471_fda402-9a .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1471_fda402-9a .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-id1471_fda402-9a 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-pane1471_fb1a13-72\"><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 (US &amp; EU)<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Product classification (SaMD vs. SiMD vs. software accessory)&nbsp;<\/li>\n\n\n\n<li>Intended use and claims shaping&nbsp;<\/li>\n\n\n\n<li>IMDRF framework and MDR Annex VIII classification&nbsp;<\/li>\n\n\n\n<li>Early regulatory pathway strategy (e.g., 510(k), De Novo, PMA, CE Mark under MDR)&nbsp;<br><strong>Documents:<\/strong> Regulatory strategy, classification rationale, initial claims matrix&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>SDLC alignment to IEC 62304, ISO 13485&nbsp;<\/li>\n\n\n\n<li>Cybersecurity planning per AAMI SW96 and ISO\/IEC 81001-5-1&nbsp;<br><strong>Documents:<\/strong> Risk management plan, draft development SOPs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Evidence needs assessment for software-specific performance and human factors&nbsp;<br><strong>Documents:<\/strong> Early clinical evidence roadmap&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Initial payer value story exploration&nbsp;<\/li>\n\n\n\n<li>Identification of digital health reimbursement pathways (e.g., NTAP, CPT codes)&nbsp;<br><strong>Documents:<\/strong> Reimbursement landscape 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>Drafting of intended use, IFU outline, early labeling strategy&nbsp;<br><strong>Documents:<\/strong> Draft IFU, Target Product Profile&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong> (Jordi Labs)&nbsp;\n<ul class=\"wp-block-list\">\n<li>Only applicable for wearable\/implantable devices with sensors&nbsp;<br><strong>Documents:<\/strong> N\/A unless hardware present&nbsp;<\/li>\n<\/ul>\n<\/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-pane1471_456d88-9a\"><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>Pre-submission strategy (FDA Q-Sub, EU NB consultations)&nbsp;<\/li>\n\n\n\n<li>Standard applicability mapping (FDA Guidance, IEC 62304, ISO 14971)&nbsp;<br><strong>Documents:<\/strong> Pre-sub package, regulatory standard applicability matrix&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Software development documentation including version control, requirements traceability&nbsp;<\/li>\n\n\n\n<li>Secure design documentation and cybersecurity control planning&nbsp;<br><strong>Documents:<\/strong> SDLC documentation, configuration management, secure design traceability&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Protocol planning for usability testing and validation&nbsp;<\/li>\n\n\n\n<li>Simulation or observational design for performance substantiation&nbsp;<br><strong>Documents:<\/strong> Usability test plan, clinical validation framework&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Planning for evidence to support payer discussions&nbsp;<br><strong>Documents:<\/strong> Preliminary value dossier outline&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Support protocol development, IFU drafting, early CER skeleton (EU)&nbsp;<br><strong>Documents:<\/strong> Draft protocol, CER framework, labeling overview&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;(Jordi Labs)\n<ul class=\"wp-block-list\">\n<li>For wearable\/implantable: initiation of device-software integration feasibility testing&nbsp;<br><strong>Documents:<\/strong> N\/A unless hybrid product<\/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-pane1471_9c779f-eb\"><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>Support for software V&amp;V documentation aligned to claims&nbsp;<\/li>\n\n\n\n<li>Traceability matrix development and Level of Concern justification&nbsp;<br><strong>Documents:<\/strong> V&amp;V summary, traceability matrix, Level of Concern documentation (FDA)&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Ensure all IEC 62304 and ISO 14971 documentation is audit-ready&nbsp;<\/li>\n\n\n\n<li>Cybersecurity verification protocols documented&nbsp;<br><strong>Documents:<\/strong> Software verification plan, risk control documentation&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Human factors validation completion&nbsp;<\/li>\n\n\n\n<li>Clinical performance summary (if applicable)&nbsp;<br><strong>Documents:<\/strong> Human factors report, validation data summary&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Alignment of V&amp;V outcomes to support cost-effectiveness arguments&nbsp;<br><strong>Documents:<\/strong> RWE synthesis for value message support&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Support compilation of V&amp;V evidence summaries for regulatory filing&nbsp;<br><strong>Documents:<\/strong> V&amp;V narrative, software summary report for FDA\/EU&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>N\/A unless wearable\/implantable software is integrated with materials&nbsp;<br><strong>Documents:<\/strong> N\/A<\/li>\n<\/ul>\n<\/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-pane1471_d68d62-02\"><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>Submission of clinical validation justifications or protocols (when required)&nbsp;<\/li>\n\n\n\n<li>Documentation alignment with MDCG 2020-1 (EU) and FDA guidance on SaMD&nbsp;<br><strong>Documents:<\/strong> Clinical protocol (if applicable), justification memo for literature\/bench data&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Ensure traceability of clinical inputs to RMF and SDLC records&nbsp;<br><strong>Documents:<\/strong> Clinical-risk linkage analysis&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Execution or oversight of human factors testing, performance validation, or literature review&nbsp;<br><strong>Documents:<\/strong> CER (EU), Clinical Evaluation Summary (US), SSCP (EU Class C\/D)&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Health economic model refinement&nbsp;<\/li>\n\n\n\n<li>Data generation aligned with payer priorities&nbsp;<br><strong>Documents:<\/strong> HEOR plan, payer evidence gap 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>Clinical Study Reports, CER updates, Post-Market Clinical Follow-Up Plans (EU)&nbsp;<br><strong>Documents:<\/strong> CSR, CER, PMCF Plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;(Jordi Labs)\n<ul class=\"wp-block-list\">\n<li>N\/A unless clinical integration with device performance&nbsp;<br><strong>Documents:<\/strong> N\/A&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-7 kt-pane1471_b84f10-3f\"><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>Finalization of submission components (510(k), De Novo, MDR Tech File)&nbsp;<\/li>\n\n\n\n<li>Labeling and UDI content review&nbsp;<br><strong>Documents:<\/strong> Labeling packet, eSTAR checklist, EU GSPR table&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Completion of QMS documentation related to software production&nbsp;<\/li>\n\n\n\n<li>Software release documentation and cybersecurity deployment validation&nbsp;<br><strong>Documents:<\/strong> Finalized DHF, SOPs for release, software change control plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Continued support for integrating usability and clinical performance outcomes into QMS&nbsp;<br><strong>Documents:<\/strong> Clinical evidence integration memo&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Prepare value proposition materials for launch market access planning&nbsp;<br><strong>Documents:<\/strong> Reimbursement dossier, payer slide deck&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 finalization, submission narratives, PMCF plan content&nbsp;<br><strong>Documents:<\/strong> Final IFU, PMCF Plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;(Jordi Labs)\n<ul class=\"wp-block-list\">\n<li>N\/A unless software controls hardware interaction in implantables&nbsp;<br><strong>Documents:<\/strong> Device-software interoperability report (if applicable)&nbsp;<\/li>\n<\/ul>\n<\/li>\n<\/ul>\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-id1471_2ccc62-ce .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:40px;}.kt-accordion-id1471_2ccc62-ce .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-id1471_2ccc62-ce .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 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.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-id1471_2ccc62-ce .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1471_2ccc62-ce .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-id1471_2ccc62-ce .kt-accordion-inner-wrap{display:block;}.kt-accordion-id1471_2ccc62-ce .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:40px;}.kt-accordion-id1471_2ccc62-ce .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-id1471_2ccc62-ce .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-id1471_2ccc62-ce .kt-accordion-header-wrap .kt-blocks-accordion-header:hover, body:not(.hide-focus-outline) .kt-accordion-id1471_2ccc62-ce .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-id1471_2ccc62-ce .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible, .kt-accordion-id1471_2ccc62-ce .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-id1471_2ccc62-ce 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-pane1471_6b1540-4d\"><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>Complete 510(k), De Novo, PMA, or MDR Tech Doc preparation and submission&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>Response to AI\/IR, RTA, Notified Body feedback&nbsp;<br><strong>Documents:<\/strong> Entire regulatory submission packet, RTA checklist, NB response memos&nbsp;<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Support linking submission to QMS audit readiness&nbsp;<br><strong>Documents:<\/strong> Quality documentation list, audit support memo&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Final submission of all clinical reports&nbsp;<br><strong>Documents:<\/strong> Clinical Summary, Clinical Evidence Table&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Initiate payer submission strategy or clinical coding review&nbsp;<br><strong>Documents:<\/strong> Coding memo, payer outreach plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Own authorship of submission content (intended use, clinical summary, labeling)&nbsp;<br><strong>Documents:<\/strong> FDA Summary of Safety and Effectiveness, EU Clinical Overview&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;(Jordi Labs)\n<ul class=\"wp-block-list\">\n<li>Not typically involved unless integrated hardware&nbsp;<br><strong>Documents:<\/strong> N\/A&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-pane1471_4813d2-8b\"><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>Marketing clearance communication, labeling compliance checks&nbsp;<br><strong>Documents:<\/strong> CE Certificate\/510(k) letter, labeling confirmation report&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Software release to production documentation&nbsp;<br><strong>Documents:<\/strong> Final DHF, deployment SOPs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Launch evidence support and post-launch surveillance setup&nbsp;<br><strong>Documents:<\/strong> Post-market plan, user feedback protocol&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Initiation of reimbursement submissions or coding applications&nbsp;<br><strong>Documents:<\/strong> Payer communication documents, CMS submission (if US)&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 implementation documents, launch messaging materials&nbsp;<br><strong>Documents:<\/strong> PMCF Report template, value-focused clinical brief&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Only applicable in hybrid wearable\/implantable products&nbsp;<br><strong>Documents:<\/strong> N\/A unless triggered by combination use<\/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-pane1471_c568a7-75\"><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>Support for periodic updates (e.g., PSURs), vigilance reporting&nbsp;<br><strong>Documents:<\/strong> PSUR (EU), MDR vigilance reporting support&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Software change control documentation support&nbsp;<br><strong>Documents:<\/strong> Change justification memos, cybersecurity update logs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>PMCF activities and registry\/RWD support&nbsp;<br><strong>Documents:<\/strong> PMCF data reports, literature monitoring logs&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Continued evidence generation for value-based care models&nbsp;<br><strong>Documents:<\/strong> Real-world outcomes tracking sheet&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Periodic update support and narrative responses&nbsp;<br><strong>Documents:<\/strong> PSUR summary, client-facing safety narrative&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Not applicable&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-pane1471_897dbd-ae\"><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. Life Cycle Management and 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>Label expansions, software feature enhancements, international registrations&nbsp;<br><strong>Documents:<\/strong> Change notification documents, global submission strategies&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Validation support documentation for updates&nbsp;<br><strong>Documents:<\/strong> Validation summary support, QMS update documentation&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Ongoing studies or new indication assessments&nbsp;<br><strong>Documents:<\/strong> Study protocols, evidence expansion map&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Global payer engagement strategy for new markets&nbsp;<br><strong>Documents:<\/strong> Global reimbursement landscape&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Authoring of regulatory justifications and updated submission components&nbsp;<br><strong>Documents:<\/strong> Clinical Addenda, Summary of Change Justification&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Not applicable&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-pane1471_558b8b-0d\"><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>Crisis response for recalls, MDR reporting, field corrective action&nbsp;<br><strong>Documents:<\/strong> Field Safety Notice, CAPA support documentation&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Quality<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>CAPA support, DHF remediation&nbsp;<br><strong>Documents:<\/strong> Root cause analysis, correction plan&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Clinical<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>RWE rescue studies or performance complaints&nbsp;<br><strong>Documents:<\/strong> Complaint analysis report&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Reimbursement<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Evidence rebuttals or coverage challenges&nbsp;<br><strong>Documents:<\/strong> Appeals support packet&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Medical Writing<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Urgent communications and supporting regulatory narratives&nbsp;<br><strong>Documents:<\/strong> Safety memo, regulator communication template&nbsp;<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Labs<\/strong>&nbsp;\n<ul class=\"wp-block-list\">\n<li>Only if linked to physical component issue&nbsp;<br><strong>Documents:<\/strong> N\/A unless combination&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<div id=\"rqm-group-block_fbdf6fc4ca61ae1a0ba4aecb43ee0fa5\" 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","protected":false},"excerpt":{"rendered":"<p>RQM+ provides regulatory, quality, clinical, post-market, and reimbursement support for medical devices and IVDs, including software-enabled products. Our expertise ensures&#8230;<\/p>\n","protected":false},"author":7,"featured_media":1492,"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-1471","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"card_info":{"title":"Software-Enabled Products","link":"https:\/\/www.rqmplus.com\/expertise\/software-enabled-products\/","link_target":"_self","name":"Page","slug":"page","thumbnail":"https:\/\/www.rqmplus.com\/wp-content\/uploads\/2025\/05\/two-scientists-discussing-robotics-research-highlighting-technological-innovation.-8439009-scaled.jpg","excerpt":"RQM+ provides regulatory, quality, clinical, post-market, and reimbursement support for medical devices and IVDs, including software-enabled products. Our expertise ensures...","display_date":"May 13, 2025"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Software | Regulatory Guidance | Digital Health<\/title>\n<meta name=\"description\" content=\"Navigate medical device software, digital health and device software regulations with expert support. 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