{"id":704,"date":"2025-07-30T08:08:27","date_gmt":"2025-07-30T08:08:27","guid":{"rendered":"http:\/\/mdx.local\/?post_type=sector&#038;p=704"},"modified":"2026-04-06T17:15:39","modified_gmt":"2026-04-06T17:15:39","slug":"medical-devices","status":"publish","type":"sector","link":"https:\/\/mdxcro.com\/fr\/sectors\/medical-devices\/","title":{"rendered":"Medical Devices"},"content":{"rendered":"\n<section id=\"block_d42ceab0dc12d95bcb885c0327093a91\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/03\/eu-ai-act-medical-devices-samd-MDX-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Medical Device Regulatory Consulting <\/h1>\n            \n                            <div class=\"description\"><p><em><strong>Excellence from Concept to Post-Market<\/strong><\/em><\/p>\n<p><span style=\"font-weight: 400;\">Navigate EU MDR compliance, clinical development, and post-market surveillance with confidence. Our former Notified Body experts deliver end-to-end solutions for Class I-III devices.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=medical_devices\" class=\"button button--default\" target=\"_self\">\n                            Book MDR Strategy Session                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/clinical-development-for-medical-devices-from-strategy-to-submission\/\" class=\"button button--secondary\" target=\"_self\">\n                            Explore Our Clinical Development Guide                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_340bc995611124b0bd1ac3a27196c3e7\" class=\"text-image\" style=\"margin-top: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Core Medical Device Expertise<\/h2><div class=\"description wysiwyg\"><p><b>Regulatory Strategy &amp; Certification<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>MDR Certification Support<\/b><span style=\"font-weight: 400\">: Gap assessments, technical documentation remediation, and Notified Body liaison<\/span><\/li>\n<li style=\"font-weight: 400\"><b>EU MDR Compliance Services<\/b><span style=\"font-weight: 400\">: Article 120 transition strategies for legacy devices<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Medical Device Regulatory Pathway<\/b><span style=\"font-weight: 400\">: Global submission planning (FDA 510(k), UKCA, Australia TGA)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Drug-Device Combination Products<\/b><span style=\"font-weight: 400\">: 21 CFR Part 4 compliance and borderline assessments<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/medical-device-expertise.jpg\" alt=\"Innovative medical robotic surgery with advanced digital interfaces and precision tools for the future of medtech and healthcare innovation.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_b5cd7605fcdd9b8d1469e99d32a4b66b\" class=\"text-image text-image--reverse\" style=\"margin-top: var(--wp--preset--spacing--regular); margin-bottom: var(--wp--preset--spacing--medium); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Clinical Evaluation Plan<\/h2><div class=\"description wysiwyg\"><p><b>Clinical Development &amp; Evidence Generation<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Clinical Development Plans<\/b><span style=\"font-weight: 400\">: ISO 14155-aligned strategies for PMCF\/clinical investigations<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Biological Evaluation Reports<\/b><span style=\"font-weight: 400\">: ISO 10993-compliant biocompatibility assessments<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Clinical Evaluation Reports (CER)<\/b><span style=\"font-weight: 400\">: MEDDEV 2.7\/1 Rev 4 and MDCG compliance with state-of-the-art analysis<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Post-Market Clinical Follow-Up (PMCF)<\/b><span style=\"font-weight: 400\">: Study design, survey implementation, and real-world evidence strategies<\/span><\/li>\n<\/ul>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-13.jpg\" alt=\"Advanced robotic surgical arm in a high-tech MedTech operating room, showcasing innovative medical device technology for improved healthcare outcomes.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"block_18eea619b393b2898bc635dfebeeb09f\" class=\"flip-cards flip-cards--four-columns \" style=\"padding-bottom: var(--wp--preset--spacing--small); \">\n        \t<div \n\t\tclass=\"component-top-icon\"\n\t\tstyle=\"--component-top-icon-height: 50px\"\n\t>\n\t\t<img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX-icon.svg\" alt=\"\" \/>\n\t<\/div>\n\t    <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Specialized Services<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">MDR Technical Documentation<\/div>\n                        <div class=\"back\"><p>Annex II\/III packages with GSPR compliance mapping<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/compliance.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Labeling Compliance<\/div>\n                        <div class=\"back\"><p>EU MDR labeling requirements &#038; IFU validation<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Remediation Services<\/div>\n                        <div class=\"back\"><p>MDD-to-MDR transition with QMS integration<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/regulatory-inteligence.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Regulatory Intelligence<\/div>\n                        <div class=\"back\"><p>Proactive monitoring of MDR amendments<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/9bcfa81f4da5af9a789e8d5503d61fa0249200ba.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Biocompatibility Testing Coordination:<\/div>\n                        <div class=\"back\"><p>ISO 10993 biological evaluation plans &amp; reports; Vendor selection for cytotoxicity\/genotoxicity studies;<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Electrical Safety &amp; EMC Testing<\/div>\n                        <div class=\"back\"><p>IEC 60601 compliance strategies<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Clinical Validation Protocols<\/div>\n                        <div class=\"back\"><p>PMCF survey design and statistical analysis plans<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--image-only\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/logo-square-black.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\"><\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n\n\n<section id=\"block_d595ba926272085d86b2c827175d8e60\" class=\"content-columns content-columns--three-columns content-columns--background-black\" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">MDR Compliance Roadmap<\/h2>\n                                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Phase 1: Pre-Submission Preparation<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Device classification per MDR Annex VIII<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Conformity assessment route selection<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Clinical development strategy alignment<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gap analysis against Annex I GSPRs<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Phase 2: Documentation &#038; Validation<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Technical file compilation (90-120 days avg.)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Biological evaluation report development<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Clinical investigation set-up per ISO 14155<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Usability engineering files per IEC 62366<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Phase 3: Certification &#038; Beyond<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Notified Body audit preparation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">SSCP creation and EUDAMED registration<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Creation of Periodic Safety Update Reports (PSURs)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Ongoing PMCF study management<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n                    <div class=\"button-wrapper\">\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_f5a5b7993d4e5bf093c9db9c14b17676\" class=\"flip-cards flip-cards--four-columns flip-cards--bg-white\" style=\"\">\n        \t<div \n\t\tclass=\"component-top-icon\"\n\t\tstyle=\"--component-top-icon-height: 80px\"\n\t>\n\t\t<img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Vector.png\" alt=\"\" \/>\n\t<\/div>\n\t    <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Differentiated Expertise<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p><b>Why Global Manufacturers Choose MDx<\/b><\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Former Notified Body Team<\/div>\n                        <div class=\"back\"><p>ex-BSI\/T\u00dcV S\u00dcD experts<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Integrated Clinical-Regulatory Approach<\/div>\n                        <div class=\"back\"><p>Synchronized CER\/PMCF timelines, including clinical investigations, if applicable.<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/complex-device-specialization-scaled.jpeg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Complex Device Specialization<\/div>\n                        <div class=\"back\"><p>68% of projects involve Class IIb\/III devices; 20+ combination product submissions<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Proven Track Record<\/div>\n                        <div class=\"back\"><p>100% MDR submission success rate; 30% faster certification vs industry average<\/p>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n\n\n<section id=\"block_37babf0f695ea76442a0c35c3c2bf83c\" class=\"case-study-details\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg&#039;);\">\n    \n    \n    <div class=\"container\">\n                    <div class=\"headline\">Why Clients Choose MDX<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/mdr-certification-for-dental-implant-manufacturer\/\">\n                                                <div class=\"subtitle\">MDR Certification for Dental Implant Manufacturer<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\">  <\/span>\n                                        <p><b>Challenge:<\/b><span style=\"font-weight: 400;\"> Class IIb manufacturer needed urgent transition from MDD to MDR with incomplete clinical data.<\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\">  <\/span>\n                                        <p><b>Solution:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Literature-based CER with PMCF gap analysis<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMCF study development<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Notified Body negotiation strategy<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\">  <\/span>\n                                        <p><b>Result:<\/b><span style=\"font-weight: 400;\"> CE Mark granted in 9 months with 60% cost savings vs new trials.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/pmcf-strategy-for-cardiovascular-device\/\">\n                                                <div class=\"subtitle\">PMCF Strategy for Cardiovascular Device<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\">  <\/span>\n                                        <p><b>Challenge:<\/b><span style=\"font-weight: 400;\"> Post-market surveillance requirements for Class IIb device with limited budget.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/solution.svg\" alt=\"\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\">  <\/span>\n                                        <p><b>Solution:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Real-world evidence collection via hybrid PMCF survey<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">ISO 14155-compliant registry study design<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Automated safety signal detection system<\/span><\/li>\n<\/ul>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/result.svg\" alt=\"\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\">  <\/span>\n                                        <p><b>Result:<\/b><span style=\"font-weight: 400;\"> Sustained compliance with 85% participant retention rate.<\/span><\/p>\n                                    <\/div>\n                                <\/div>\n                            <\/div>\n                                                <\/div>\n                    <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                <a href=\"\/resources\/?category=case-studies\" class=\"button button--tertiary\">View Case Studies<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n\n<section id=\"block_6311c5c19d956f78c5150bc3b849edf1\" class=\"faqs\" style=\"\">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Frequently Asked Questions<\/h2>\n                          <a class=\"button button--quaternary\" href=\"https:\/\/mdxcro.com\/contact\/\" target=\"\">\n            Ask us a Question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What&#039;s included in a biological evaluation report?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Our ISO 10993-compliant reports include material evaluation, including the type and duration of body contact, as well as potential biological risks. They include a review of existing data, material characterization, and toxicological risk assessment. Where applicable, additional testing to address required biological endpoints can be conducted &#8211; all coordinated with accredited test labs.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">How long does MDR certification typically take?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Most devices achieve certification in 6-18 months. Our phased approach reduces timelines by 40% through parallel documentation\/validation processes.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What distinguishes your PMCF services?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">We implement risk-based PMCF strategies combining literature reviews, registry studies, and real-world data analytics to minimize clinical trial costs.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">What should a Clinical Evaluation Plan include?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">A Clinical Evaluation Plan (CEP) is required under EU MDR 2017\/745 Annex XIV, Part A, and must document the following elements:<\/p>\n<ul class=\"[li_&amp;]:mb-0 [li_&amp;]:mt-1 [li_&amp;]:gap-1 [&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3\">\n<li class=\"whitespace-normal break-words pl-2\"><strong>Device description and intended purpose<\/strong> \u2014 including indications, target population, and clinical claims to be substantiated<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Device classification and applicable GSPRs<\/strong> \u2014 specifically those requiring clinical evidence<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Description of equivalent devices<\/strong> (if equivalence is claimed) \u2014 including the technical, biological, and clinical characteristics used to justify equivalence<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Clinical background and state of the art<\/strong> \u2014 defining the current standard of care against which the device will be evaluated<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Literature search methodology<\/strong> \u2014 databases, search strings, inclusion\/exclusion criteria, and appraisal methodology (in line with MDCG 2020-13)<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Clinical data sources to be used<\/strong> \u2014 own clinical investigations, PMCF data, registry data, published literature, and\/or post-market surveillance data<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Acceptance criteria<\/strong> \u2014 defining what level of clinical evidence will be sufficient to demonstrate conformity with the relevant GSPRs<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Reference to related documents<\/strong> \u2014 linking to the PMCF plan, risk management file, and PMS plan<\/li>\n<\/ul>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">The CEP must be updated throughout the device lifecycle and reviewed as part of each periodic clinical evaluation cycle.<\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                      <\/ul>\n              <\/div>\n    <\/div>\n  <\/div>\n<\/section>\n\n  <script type=\"application\/ld+json\">\n    {\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What's included in a biological evaluation report?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Our ISO 10993-compliant reports include material evaluation, including the type and duration of body contact, as well as potential biological risks. They include a review of existing data, material characterization, and toxicological risk assessment. Where applicable, additional testing to address required biological endpoints can be conducted &#8211; all coordinated with accredited test labs.\"}},{\"@type\":\"Question\",\"name\":\"How long does MDR certification typically take?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Most devices achieve certification in 6-18 months. Our phased approach reduces timelines by 40% through parallel documentation\/validation processes.\"}},{\"@type\":\"Question\",\"name\":\"What distinguishes your PMCF services?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"We implement risk-based PMCF strategies combining literature reviews, registry studies, and real-world data analytics to minimize clinical trial costs.\"}},{\"@type\":\"Question\",\"name\":\"What should a Clinical Evaluation Plan include?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"A Clinical Evaluation Plan (CEP) is required under EU MDR 2017\/745 Annex XIV, Part A, and must document the following elements:\\n\\nDevice description and intended purpose \u2014 including indications, target population, and clinical claims to be substantiated\\nDevice classification and applicable GSPRs \u2014 specifically those requiring clinical evidence\\nDescription of equivalent devices (if equivalence is claimed) \u2014 including the technical, biological, and clinical characteristics used to justify equivalence\\nClinical background and state of the art \u2014 defining the current standard of care against which the device will be evaluated\\nLiterature search methodology \u2014 databases, search strings, inclusion\/exclusion criteria, and appraisal methodology (in line with MDCG 2020-13)\\nClinical data sources to be used \u2014 own clinical investigations, PMCF data, registry data, published literature, and\/or post-market surveillance data\\nAcceptance criteria \u2014 defining what level of clinical evidence will be sufficient to demonstrate conformity with the relevant GSPRs\\nReference to related documents \u2014 linking to the PMCF plan, risk management file, and PMS plan\\n\\nThe CEP must be updated throughout the device lifecycle and reviewed as part of each periodic clinical evaluation cycle.\"}}]}  <\/script>\n\n\n\n<section id=\"block_e057844c510d0907ce3e463df3831d46\" class=\"call-to-action\" style=\"\">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Accelerate Your Medical Device Compliance<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Whether you&rsquo;re navigating MDR certification, developing clinical evidence, or managing post-market requirements &#8211; MDx delivers turnkey regulatory success.<\/span><\/p>\n<p><b>From Biological Evaluation to Market Success. We Deliver.<\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/contact\/?utm_source=medical_devices\" class=\"button button--tertiary\" target=\"\">\n                                Book a Discovery Call                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/mdr-compliance-checklist-what-you-need-before-submitting\/\" class=\"button button--secondary\" target=\"\">\n                                Review Your MDR Readiness                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":true},"class_list":["post-704","sector","type-sector","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device CRO &amp; Regulatory Consulting | Former NB Experts<\/title>\n<meta name=\"description\" content=\"MDR certification, CERs, clinical evaluation plans, and PMCF, delivered by former BSI &amp; T\u00dcV S\u00dcD experts. 100% MDR submission success rate. 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