{"id":12091,"date":"2025-07-30T08:08:27","date_gmt":"2025-07-30T08:08:27","guid":{"rendered":"https:\/\/mdxcro.com\/sectors\/dispositifs-medicaux\/"},"modified":"2026-07-22T10:05:43","modified_gmt":"2026-07-22T10:05:43","slug":"dispositifs-medicaux","status":"publish","type":"sector","link":"https:\/\/mdxcro.com\/fr\/sectors\/dispositifs-medicaux\/","title":{"rendered":"Dispositifs m\u00e9dicaux"},"content":{"rendered":"\n<section id=\"block_d132417ede9a716bb30d0e46c6030ac1\" 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\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Conseil r\u00e9glementaire pour dispositifs m\u00e9dicaux  <\/h1>\n            \n                            <div class=\"description\"><p><em><strong>L\u2019excellence du concept au post-market<\/strong><\/em><\/p>\n<p><span style=\"font-weight: 400;\">Abordez en toute confiance la conformit\u00e9 au MDR de l\u2019UE, le d\u00e9veloppement clinique et la surveillance post-commercialisation. Nos anciens experts d\u2019organismes notifi\u00e9s fournissent des solutions de bout en bout pour les dispositifs de classe I \u00e0 III. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=medical_devices\" class=\"button button--default\" target=\"_self\">\n                            R\u00e9server une session de strat\u00e9gie MDR                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/clinical-development-for-medical-devices-from-strategy-to-submission\/\" class=\"button button--secondary\" target=\"_self\">\n                            D\u00e9couvrir notre guide de d\u00e9veloppement clinique                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_cd03e936b2b4ea0c9d116e9f72fa7fe8\" 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\">Expertise cl\u00e9 en dispositifs m\u00e9dicaux<\/h2><div class=\"description wysiwyg\"><p><b>Strat\u00e9gie r\u00e9glementaire &#038; certification<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Support \u00e0 la certification MDR<\/b><span style=\"font-weight: 400\"> : analyses d\u2019\u00e9carts, rem\u00e9diation de la documentation technique et liaison avec l\u2019organisme notifi\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Services de conformit\u00e9 au MDR de l\u2019UE<\/b><span style=\"font-weight: 400\"> : strat\u00e9gies de transition de l\u2019article 120 pour les dispositifs h\u00e9rit\u00e9s<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Parcours r\u00e9glementaire des dispositifs m\u00e9dicaux<\/b><span style=\"font-weight: 400\"> : planification des soumissions internationales (FDA 510(k), UKCA, Australie TGA)<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Produits combin\u00e9s m\u00e9dicament-dispositif<\/b><span style=\"font-weight: 400\"> : conformit\u00e9 \u00e0 la 21 CFR Part 4 et \u00e9valuations de borderline<\/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<section id=\"block_0a1bc02999ec98d33e0432d55ac789a5\" 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\">Plan d\u2019\u00e9valuation clinique<\/h2><div class=\"description wysiwyg\"><p><b>D\u00e9veloppement clinique &#038; g\u00e9n\u00e9ration de preuves<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400\"><b>Plans de d\u00e9veloppement clinique<\/b><span style=\"font-weight: 400\"> : strat\u00e9gies align\u00e9es sur l\u2019ISO 14155 pour le PMCF\/les investigations cliniques<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Rapports d\u2019\u00e9valuation biologique<\/b><span style=\"font-weight: 400\"> : \u00e9valuations de biocompatibilit\u00e9 conformes \u00e0 l\u2019ISO 10993<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Rapports d\u2019\u00e9valuation clinique (CER)<\/b><span style=\"font-weight: 400\"> : conformit\u00e9 MEDDEV 2.7\/1 Rev 4 et MDCG avec analyse de l\u2019\u00e9tat de l\u2019art<\/span><\/li>\n<li style=\"font-weight: 400\"><b>Suivi clinique post-commercialisation (PMCF)<\/b><span style=\"font-weight: 400\"> : conception d\u2019\u00e9tudes, mise en \u0153uvre d\u2019enqu\u00eates et strat\u00e9gies de preuves en vie r\u00e9elle<\/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<section id=\"block_490f1f0a5db2c4e0f94bcf8709054711\" 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\">Services sp\u00e9cialis\u00e9s<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Documentation technique MDR<\/div>\n                        <div class=\"back\"><p>Dossiers Annexes II\/III avec cartographie de conformit\u00e9 aux GSPR<\/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\">Conformit\u00e9 de l\u2019\u00e9tiquetage<\/div>\n                        <div class=\"back\"><p>Exigences d\u2019\u00e9tiquetage MDR UE &#038; validation des IFU<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Services de rem\u00e9diation<\/div>\n                        <div class=\"back\"><p>Transition MDD vers MDR avec int\u00e9gration au SMQ<\/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\">Veille r\u00e9glementaire<\/div>\n                        <div class=\"back\"><p>Surveillance proactive des modifications du MDR<\/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\">Coordination des essais de biocompatibilit\u00e9 :<\/div>\n                        <div class=\"back\"><p>Plans &#038; rapports d\u2019\u00e9valuation biologique ISO 10993 ; s\u00e9lection de prestataires pour les \u00e9tudes de cytotoxicit\u00e9\/g\u00e9notoxicit\u00e9 ;<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">S\u00e9curit\u00e9 \u00e9lectrique &amp; essais CEM<\/div>\n                        <div class=\"back\"><p>Strat\u00e9gies de conformit\u00e9 \u00e0 l\u2019IEC 60601<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Protocoles de validation clinique<\/div>\n                        <div class=\"back\"><p>Conception d\u2019enqu\u00eates PMCF et plans d\u2019analyse statistique<\/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<section id=\"block_989743c8e13233fa969135324ffa92f2\" class=\"content-columns content-columns--three-columns content-columns--background-black\" style=\"\">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Feuille de route de conformit\u00e9 MDR<\/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 : Pr\u00e9paration pr\u00e9-soumission<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li><span style=\"font-weight: 400\">Classification du dispositif selon l\u2019annexe VIII du MDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">S\u00e9lection de la proc\u00e9dure d\u2019\u00e9valuation de la conformit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Alignement de la strat\u00e9gie de d\u00e9veloppement clinique<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Analyse d\u2019\u00e9carts par rapport aux GSPR de l\u2019annexe I<\/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\">Compilation du dossier technique (90-120 jours en moyenne)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9laboration du rapport d\u2019\u00e9valuation biologique<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Mise en place de l\u2019investigation clinique selon l\u2019ISO 14155<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Dossiers d\u2019ing\u00e9nierie de l\u2019utilisabilit\u00e9 selon l\u2019IEC 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; au-del\u00e0<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Pr\u00e9paration \u00e0 l\u2019audit de l\u2019organisme notifi\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Cr\u00e9ation du SSCP et enregistrement EUDAMED<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Cr\u00e9ation des rapports p\u00e9riodiques actualis\u00e9s de s\u00e9curit\u00e9 (PSUR)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gestion continue des \u00e9tudes PMCF<\/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<section id=\"block_bfcc5b08e3723930fd650d9252c6361a\" 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\">Une expertise diff\u00e9renciante<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p><b>Pourquoi les fabricants internationaux choisissent 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\">Ancienne \u00e9quipe d\u2019organisme notifi\u00e9<\/div>\n                        <div class=\"back\"><p>anciens experts BSI\/T\u00dcV S\u00dcD<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Approche clinique-r\u00e9glementaire int\u00e9gr\u00e9e<\/div>\n                        <div class=\"back\"><p>Calendriers CER\/PMCF synchronis\u00e9s, y compris les investigations cliniques, le cas \u00e9ch\u00e9ant.<\/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\">Sp\u00e9cialisation dans les dispositifs complexes<\/div>\n                        <div class=\"back\"><p>68 % des projets concernent des dispositifs de classe IIb\/III ; plus de 20 soumissions de produits combin\u00e9s<\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Un historique \u00e9prouv\u00e9<\/div>\n                        <div class=\"back\"><p>Taux de r\u00e9ussite de 100 % des soumissions MDR ; certification 30 % plus rapide que la moyenne du secteur<\/p>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_b58078c29842ef55a221db8d53a0bd23\" 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\">Pourquoi les clients choisissent 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<section id=\"block_dc34518620cdc89810bac12cef1cccff\" class=\"faqs\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quemment pos\u00e9es<\/h2>\n                          <a class=\"button button--quaternary\" href=\"https:\/\/mdxcro.com\/fr\/contact\/\" target=\"\">\n            Posez-nous une question          <\/a>\n              <\/div>\n      <div class=\"column\">\n                  <ul class=\"faq-list\">\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Que contient un rapport d\u2019\u00e9valuation biologique ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nos rapports conformes \u00e0 l\u2019ISO 10993 incluent l\u2019\u00e9valuation des mat\u00e9riaux, notamment le type et la dur\u00e9e du contact avec le corps, ainsi que les risques biologiques potentiels. Ils comprennent une revue des donn\u00e9es existantes, la caract\u00e9risation des mat\u00e9riaux et l\u2019\u00e9valuation du risque toxicologique. Le cas \u00e9ch\u00e9ant, des essais suppl\u00e9mentaires pour couvrir les crit\u00e8res biologiques requis peuvent \u00eatre r\u00e9alis\u00e9s \u2014 le tout coordonn\u00e9 avec des laboratoires d\u2019essais accr\u00e9dit\u00e9s.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Combien de temps prend g\u00e9n\u00e9ralement une certification MDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La plupart des dispositifs obtiennent la certification en 6 \u00e0 18 mois. Notre approche par phases r\u00e9duit les d\u00e9lais de 40 % gr\u00e2ce \u00e0 des processus parall\u00e8les de documentation\/validation. <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qu\u2019est-ce qui distingue vos services PMCF ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nous mettons en \u0153uvre des strat\u00e9gies PMCF fond\u00e9es sur les risques, combinant revues de litt\u00e9rature, \u00e9tudes de registres et analyses de donn\u00e9es en vie r\u00e9elle afin de minimiser les co\u00fbts des essais cliniques.<\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Que doit inclure un plan d\u2019\u00e9valuation clinique ?<\/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]\">Un plan d\u2019\u00e9valuation clinique (CEP) est requis au titre du MDR UE 2017\/745, annexe XIV, partie A, et doit documenter les \u00e9l\u00e9ments suivants :<\/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>Description du dispositif et destination pr\u00e9vue<\/strong> \u2014 y compris les indications, la population cible et les all\u00e9gations cliniques \u00e0 \u00e9tayer<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Classification du dispositif et GSPR applicables<\/strong> \u2014 en particulier ceux n\u00e9cessitant des preuves cliniques<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Description des dispositifs \u00e9quivalents<\/strong> (si l\u2019\u00e9quivalence est revendiqu\u00e9e) \u2014 y compris les caract\u00e9ristiques techniques, biologiques et cliniques utilis\u00e9es pour justifier l\u2019\u00e9quivalence<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Contexte clinique et \u00e9tat de l\u2019art<\/strong> \u2014 d\u00e9finissant le standard de soins actuel par rapport auquel le dispositif sera \u00e9valu\u00e9<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>M\u00e9thodologie de recherche bibliographique<\/strong> \u2014 bases de donn\u00e9es, cha\u00eenes de recherche, crit\u00e8res d\u2019inclusion\/exclusion et m\u00e9thodologie d\u2019\u00e9valuation (conform\u00e9ment au MDCG 2020-13)<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Sources de donn\u00e9es cliniques \u00e0 utiliser<\/strong> \u2014 investigations cliniques propres, donn\u00e9es PMCF, donn\u00e9es de registres, litt\u00e9rature publi\u00e9e et\/ou donn\u00e9es de surveillance post-commercialisation<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>Crit\u00e8res d\u2019acceptation<\/strong> \u2014 d\u00e9finissant le niveau de preuves cliniques suffisant pour d\u00e9montrer la conformit\u00e9 aux GSPR pertinents<\/li>\n<li class=\"whitespace-normal break-words pl-2\"><strong>R\u00e9f\u00e9rence aux documents connexes<\/strong> \u2014 lien vers le plan PMCF, le dossier de gestion des risques et le plan de PMS<\/li>\n<\/ul>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Le CEP doit \u00eatre mis \u00e0 jour tout au long du cycle de vie du dispositif et revu dans le cadre de chaque cycle p\u00e9riodique d\u2019\u00e9valuation clinique.<\/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\":\"Que contient un rapport d\u2019\u00e9valuation biologique ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nos rapports conformes \u00e0 l\u2019ISO 10993 incluent l\u2019\u00e9valuation des mat\u00e9riaux, notamment le type et la dur\u00e9e du contact avec le corps, ainsi que les risques biologiques potentiels. Ils comprennent une revue des donn\u00e9es existantes, la caract\u00e9risation des mat\u00e9riaux et l\u2019\u00e9valuation du risque toxicologique. Le cas \u00e9ch\u00e9ant, des essais suppl\u00e9mentaires pour couvrir les crit\u00e8res biologiques requis peuvent \u00eatre r\u00e9alis\u00e9s \u2014 le tout coordonn\u00e9 avec des laboratoires d\u2019essais accr\u00e9dit\u00e9s.\"}},{\"@type\":\"Question\",\"name\":\"Combien de temps prend g\u00e9n\u00e9ralement une certification MDR ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La plupart des dispositifs obtiennent la certification en 6 \u00e0 18 mois. 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Nous livrons. <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=medical_devices\" class=\"button button--tertiary\" target=\"\">\n                                R\u00e9server un appel de d\u00e9couverte                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/mdr-compliance-checklist-what-you-need-before-submitting\/\" class=\"button button--secondary\" target=\"\">\n                                \u00c9valuez votre niveau de pr\u00e9paration au MDR                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-12091","sector","type-sector","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO pour dispositifs m\u00e9dicaux &amp; conseil r\u00e9glementaire | Anciens experts d\u2019organismes notifi\u00e9s<\/title>\n<meta name=\"description\" content=\"Certification MDR, CER, plans d\u2019\u00e9valuation clinique et PMCF, assur\u00e9s par d\u2019anciens experts de BSI &amp; T\u00dcV S\u00dcD. 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