{"id":11855,"date":"2025-09-19T11:20:09","date_gmt":"2025-09-19T11:20:09","guid":{"rendered":"https:\/\/mdxcro.com\/services\/logiciel-sante-numerique-ia\/"},"modified":"2026-07-22T10:10:16","modified_gmt":"2026-07-22T10:10:16","slug":"logiciels-sante-numerique-ia","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/logiciels-sante-numerique-ia\/","title":{"rendered":"Logiciels, sant\u00e9 num\u00e9rique et IA"},"content":{"rendered":"\n<section id=\"block_edc34e4e239f093ddfe58dd18566bbb7\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/sectors-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Une expertise r\u00e9glementaire en logiciels, sant\u00e9 num\u00e9rique et IA qui acc\u00e9l\u00e8re l\u2019obtention des autorisations \u00e0 l\u2019international<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">De la classification SaMD et la validation IEC 62304 aux diagnostics bas\u00e9s sur l\u2019IA sous IVDR\/MDR et \u00e0 la conformit\u00e9 \u00e0 l\u2019AI Act, MDx CRO vous apporte l\u2019expertise sp\u00e9cialis\u00e9e dont vous avez besoin pour r\u00e9ussir sur le plan r\u00e9glementaire en sant\u00e9 num\u00e9rique.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=software_dig_ai\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            Prendre rendez-vous                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/ressources\/?resources-sector=digital-health-ai\" class=\"button bouton--secondaire\" target=\"_self\">\n                            Explorer nos ressources                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_aa76ba67769fd05ef25fc911b119be9a\" class=\"sticky-navbar\" 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                <ul class=\"list\">\n                    <li class=\"item\">\n                            <a href=\"#Overview\" class=\"link\" target=\"\"> \n                    Aper\u00e7u \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#SaMD-Solutions\" class=\"link\" target=\"\"> \n                    Solutions SaMD \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#AI-&#038;-Machine-Learning\" class=\"link\" target=\"\"> \n                    IA et apprentissage automatique \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Digital-Health-&#038;-Mobile\" class=\"link\" target=\"\"> \n                    Sant\u00e9 num\u00e9rique et mobile \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Technical-Documentation\" class=\"link\" target=\"\"> \n                    Documentation technique \n                <\/a>\n                            <\/ul>\n                \n    <\/div>\n<\/section>\n\n<section id=\"Overview\" class=\"text-image\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: 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\">Un accompagnement r\u00e9glementaire sp\u00e9cialis\u00e9 pour l\u2019innovation num\u00e9rique<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">\u00c0 mesure que les logiciels transforment la prestation des soins, les fabricants font face \u00e0 des d\u00e9fis r\u00e9glementaires de plus en plus complexes dans <\/span><b>le d\u00e9veloppement SaMD, les solutions de sant\u00e9 num\u00e9rique et les diagnostics pilot\u00e9s par l\u2019IA<\/b><span style=\"font-weight: 400\">. MDx CRO fournit une expertise r\u00e9glementaire et clinique sp\u00e9cialis\u00e9e pour naviguer dans ces cadres en \u00e9volution \u2014 de la conformit\u00e9 \u00e0 l\u2019IEC 62304 et la validation logicielle \u00e0 la classification des risques selon l\u2019AI Act et aux \u00e9tudes de performance clinique.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Notre \u00e9quipe de sp\u00e9cialistes r\u00e9glementaires du logiciel, d\u2019anciens \u00e9valuateurs d\u2019organismes notifi\u00e9s et d\u2019experts en sant\u00e9 num\u00e9rique fournit <\/span><b>un accompagnement cibl\u00e9 \u00e0 chaque \u00e9tape du cycle de vie de votre produit num\u00e9rique<\/b><span style=\"font-weight: 400\">. Que vous d\u00e9veloppiez un algorithme de diagnostic bas\u00e9 sur l\u2019IA, une application de sant\u00e9 mobile ou un SaMD complexe int\u00e9gr\u00e9 \u00e0 un dispositif physique, nous apportons l\u2019expertise n\u00e9cessaire pour acc\u00e9l\u00e9rer l\u2019obtention des autorisations r\u00e9glementaires tout en garantissant la conformit\u00e9 au MDR, \u00e0 l\u2019IVDR, \u00e0 la FDA et aux r\u00e9glementations \u00e9mergentes sur l\u2019IA.<\/span><\/p>\n<\/div><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/leadership4-scaled.jpg\" alt=\"Innovative medical technology discussion at MDX Accelerating MedTech event featuring professional collaboration and digital health solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"SaMD-Solutions\" class=\"content-columns content-columns--four-columns \" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--small); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                    <h2 class=\"title\">Services cl\u00e9s en logiciels et sant\u00e9 num\u00e9rique<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p><b>Solutions r\u00e9glementaires pour les logiciels en tant que dispositif m\u00e9dical (SaMD)<\/b><\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Classification SaMD et strat\u00e9gie r\u00e9glementaire<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9valuation de la classification logicielle MDR\/IVDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9termination du parcours r\u00e9glementaire mondial<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Feuille de route strat\u00e9gique pour les march\u00e9s UE, US et internationaux<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Classification selon l\u2019AI Act et \u00e9valuation de l\u2019impact r\u00e9glementaire<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Planification de la structure documentaire et analyse des \u00e9carts<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Mise en \u0153uvre et conformit\u00e9 IEC 62304<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation du cycle de vie de d\u00e9veloppement logiciel (SDLC)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Classification de s\u00e9curit\u00e9 logicielle et gestion des risques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gestion de configuration et ma\u00eetrise des changements<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation de l\u2019architecture et de la conception d\u00e9taill\u00e9e<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Int\u00e9gration avec la gestion des risques ISO 14971<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Planification de la v\u00e9rification et de la validation logicielle<\/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\">V\u00e9rification et validation logicielles<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9laboration et ex\u00e9cution des plans de test<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Protocoles et rapports de v\u00e9rification logicielle<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tests d\u2019int\u00e9gration et validation au niveau syst\u00e8me<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Ing\u00e9nierie de l\u2019utilisabilit\u00e9 (IEC 62366) pour les interfaces logicielles<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Tests de performance pour les algorithmes IA\/ML<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Planification de la validation clinique des fonctionnalit\u00e9s logicielles<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Conformit\u00e9 en cybers\u00e9curit\u00e9<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9valuation des risques de cybers\u00e9curit\u00e9 des dispositifs m\u00e9dicaux<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation des exigences de s\u00e9curit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Mod\u00e9lisation des menaces et analyse des vuln\u00e9rabilit\u00e9s<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Conformit\u00e9 cybers\u00e9curit\u00e9 MDCG 2019-16 et FDA<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Plans de surveillance de la s\u00e9curit\u00e9 post-commercialisation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gestion et documentation des mises \u00e0 jour de s\u00e9curit\u00e9<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"AI-&amp;-Machine-Learning\" class=\"content-columns content-columns--four-columns content-columns--background-white\" style=\"padding-top: var(--wp--preset--spacing--regular); 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                                                    <div class=\"description wysiwyg\">\n                        <p><b>Accompagnement r\u00e9glementaire IA et apprentissage automatique<\/b><\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Conformit\u00e9 des dispositifs m\u00e9dicaux bas\u00e9s sur l\u2019IA<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9valuation de la conformit\u00e9 \u00e0 l\u2019AI Act et documentation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Strat\u00e9gies de validation des algorithmes IA\/ML<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Approches r\u00e9glementaires pour les syst\u00e8mes \u00e0 apprentissage continu<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Surveillance des performances des algorithmes adaptatifs<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">G\u00e9n\u00e9ration de preuves cliniques pour les diagnostics bas\u00e9s sur l\u2019IA<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation sur l\u2019explicabilit\u00e9 et la transparence<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Diagnostics IA sous IVDR<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9tudes de performance clinique pour les DIV pilot\u00e9s par l\u2019IA<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Plans d\u2019\u00e9valuation des performances pour les diagnostics bas\u00e9s sur des algorithmes<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9valuation de la validit\u00e9 scientifique des biomarqueurs<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation et documentation des jeux de donn\u00e9es de r\u00e9f\u00e9rence<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Classification IVDR et \u00e9valuation de conformit\u00e9 pour les solutions IA<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation technique pour l\u2019aide \u00e0 la d\u00e9cision bas\u00e9e sur des algorithmes<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Gestion des changements pour les syst\u00e8mes IA\/ML<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Proc\u00e9dures de ma\u00eetrise des changements pour les algorithmes \u00e9volutifs<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Contr\u00f4le de version des algorithmes et documentation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9termination des changements significatifs<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gestion des mises \u00e0 jour et des mont\u00e9es de version<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Surveillance post-commercialisation de la d\u00e9rive des performances de l\u2019IA<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Notifications r\u00e9glementaires pour les modifications d\u2019algorithmes<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"Digital-Health-&amp;-Mobile\" class=\"content-columns content-columns--four-columns \" style=\"padding-top: var(--wp--preset--spacing--small); padding-bottom: var(--wp--preset--spacing--regular); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                                    <div class=\"description wysiwyg\">\n                        <p><b>Sant\u00e9 num\u00e9rique et applications mobiles<\/b><\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-blue\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Applications mHealth et sant\u00e9 num\u00e9rique<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Qualification et classification des applications m\u00e9dicales<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9termination des cas limites (borderline) pour les logiciels<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9valuation \u00ab bien-\u00eatre \u00bb vs finalit\u00e9 m\u00e9dicale<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Strat\u00e9gie r\u00e9glementaire pour les th\u00e9rapies num\u00e9riques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Consid\u00e9rations de conformit\u00e9 pour la surveillance \u00e0 distance<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9veloppement du parcours r\u00e9glementaire MDR\/IVDR<\/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\">Syst\u00e8mes de dispositifs m\u00e9dicaux connect\u00e9s<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation et validation de l\u2019interop\u00e9rabilit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">\u00c9valuation des risques au niveau syst\u00e8me<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Consid\u00e9rations r\u00e9glementaires pour l\u2019int\u00e9gration cloud<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Conformit\u00e9 en s\u00e9curit\u00e9 des donn\u00e9es et protection de la vie priv\u00e9e<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation des protocoles de communication<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation des tests d\u2019int\u00e9gration syst\u00e8me<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"Technical-Documentation\" class=\"flip-cards flip-cards--three-columns flip-cards--bg-white\" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--regular); \">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Services sp\u00e9cialis\u00e9s de documentation technique<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p><b>Documentation compl\u00e8te SaMD et sant\u00e9 num\u00e9rique<\/b><\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white-frost\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">D\u00e9veloppement de la documentation technique<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Compilation compl\u00e8te du <\/span><a href=\"https:\/\/mdxcro.com\/services\/regulatory-affairs-technical-documentation\/\"><span style=\"font-weight: 400;\">dossier technique MDR\/IVDR<\/span><\/a><span style=\"font-weight: 400;\"><\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Organisation de la documentation de d\u00e9veloppement logiciel<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Description de l\u2019algorithme et all\u00e9gations de performance<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuation clinique\/\u00e9valuation des performances pour les fonctions logicielles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation de soumission \u00e0 la FDA<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation de conformit\u00e9 \u00e0 l\u2019AI Act<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">G\u00e9n\u00e9ration de preuves cliniques<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification de l\u2019\u00e9valuation clinique pour les logiciels<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Compilation des preuves fond\u00e9es sur la litt\u00e9rature<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><a href=\"https:\/\/mdxcro.com\/services\/medtech-clinical-solutions\/\"><span style=\"font-weight: 400;\">Conception d\u2019investigation clinique<\/span><\/a><span style=\"font-weight: 400;\"> pour les fonctions logicielles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9tudes de validation utilisateur et \u00e9laboration des protocoles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse statistique des performances de l\u2019algorithme<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuation des preuves cliniques pour les syst\u00e8mes bas\u00e9s sur l\u2019IA<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Gestion de la qualit\u00e9 et ma\u00eetrise des risques<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Proc\u00e9dures de gestion de la qualit\u00e9 sp\u00e9cifiques aux logiciels<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9laboration du dossier de gestion des risques (ISO 14971)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">SOP de v\u00e9rification et de validation logicielles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Proc\u00e9dures de mise en production des dispositifs m\u00e9dicaux logiciels<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Proc\u00e9dures de gestion de configuration<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Ma\u00eetrise de la conception pour le d\u00e9veloppement logiciel<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section><section class=\"table\"><div class=\"container\"><div class=\"headline\">Notre expertise en sant\u00e9 num\u00e9rique fait la diff\u00e9rence<\/div><div class=\"table-wrapper\"><div class=\"feature-column-wrapper\"><table class=\"feature-table\"><thead><tr><th class=\"feature-column\">Capacit\u00e9<\/th><\/tr><\/thead><tbody><tr><td class=\"feature-cell\"><strong>Expertise en classification logicielle<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Conformit\u00e9 \u00e0 l\u2019AI Act<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Approche r\u00e9glementaire et clinique int\u00e9gr\u00e9e<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Validation clinique pour les logiciels<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Documentation IEC 62304<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Int\u00e9gration de la cybers\u00e9curit\u00e9<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Gestion des changements logiciels<\/strong><\/td><\/tr><\/tbody><\/table><\/div><div class=\"scrollable-columns-wrapper\"><table class=\"comparison-table\"><thead><tr><th class=\"column highlight\">MDx CRO<\/th><th class=\"column\">Consultants typiques<\/th><\/tr><\/thead><tbody><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Anciens \u00e9valuateurs d\u2019ON avec un focus logiciel MDR\/IVDR<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Compr\u00e9hension limit\u00e9e des cas limites (borderline)<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Conseils proactifs sur les r\u00e9glementations \u00e9mergentes<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Souvent r\u00e9actifs ou peu familiers<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Strat\u00e9gie compl\u00e8te de validation logicielle<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Services souvent fragment\u00e9s<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Protocoles sp\u00e9cialis\u00e9s pour les preuves cliniques logiciel\/IA<\/td><td class=\"cell\"><img decoding=\"async\" width=\"22\" height=\"22\" class=\"wp-image-7062 icon\" style=\"width: 22px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/x-1.svg\" alt=\"\">Approches cliniques g\u00e9n\u00e9riques<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Accompagnement complet du cycle de vie de d\u00e9veloppement logiciel<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Couverture partielle<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Approche holistique int\u00e9grant la s\u00e9curit\u00e9 au r\u00e9glementaire<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Services souvent s\u00e9par\u00e9s<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"20\" height=\"17\" class=\"wp-image-7058 icon\" style=\"width: 20px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/check-white-1.svg\" alt=\"\">Strat\u00e9gies pour les logiciels \u00e9volutifs et l\u2019IA\/ML<\/td><td class=\"cell\"><img decoding=\"async\" width=\"24\" height=\"24\" class=\"wp-image-7068 icon\" style=\"width: 24px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/half-half-blue.svg\" alt=\"\">Focus post-commercialisation limit\u00e9<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section class=\"key-stats\"  style=\"\">\n    <div class=\"container\">\n          <div class=\"headline\">Indicateurs de r\u00e9ussite<\/div>\n    \n    <div class=\"main-wrapper\">\n              <div class=\"box-grid\">\n                                    <div class=\"box\">\n                                  <div class=\"value\">15+  <\/div>\n                                                  <div class=\"legend\">Produits SaMD\/MDSW marqu\u00e9s CE avec succ\u00e8s sous MDR\/IVDR<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">100%<\/div>\n                                                  <div class=\"legend\">taux de r\u00e9ussite en documentation technique pour les composants logiciels<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">1er<\/div>\n                                                  <div class=\"legend\">solutions bas\u00e9es sur l\u2019IA mises sur le march\u00e9<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">ISO<\/div>\n                                                  <div class=\"legend\">Couverture de bout en bout des normes 62304, 82304-1, 62366, 14971<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n<section id=\"block_45df7efb060912ce8e58423ad9d69092\" class=\"flip-cards flip-cards--three-columns \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Notre approche SaMD et sant\u00e9 num\u00e9rique<\/h2>\n            \n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">1.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">\u00c9valuation et classification<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9termination de la qualification et de la classification du logiciel<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Identification du parcours r\u00e9glementaire<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse des \u00e9carts par rapport aux normes pertinentes<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">2.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Planification strat\u00e9gique<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Structure documentaire et plan de d\u00e9veloppement<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Strat\u00e9gie de preuves cliniques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification de la v\u00e9rification et de la validation<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">3.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Accompagnement \u00e0 la mise en \u0153uvre<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement de la documentation technique<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">V\u00e9rification et validation logicielles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Ing\u00e9nierie de l\u2019utilisabilit\u00e9 et gestion des risques<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">4.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">G\u00e9n\u00e9ration de preuves cliniques<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuation clinique des fonctionnalit\u00e9s logicielles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9tudes de validation utilisateur<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse des performances des algorithmes d\u2019IA<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">5.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Gestion des soumissions r\u00e9glementaires<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Compilation du dossier technique<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Accompagnement des interactions avec l\u2019organisme notifi\u00e9\/la FDA<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Gestion des r\u00e9ponses et suivi<\/span><\/li>\n<\/ul>\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\/09\/logo-card-rectangle-blue.png&#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_09ca0f2d3a765c53a363b442be2a71e9\" class=\"case-study-details\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/partner.jpg&#039;);\">\n    \n    \n    <div class=\"container\">\n                    <div class=\"headline\">\u00c9tudes de Cas<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\" data-button-url=\"https:\/\/mdxcro.com\/fr\/case-studies\/ai-driven-diagnostic-algorithm\/\">\n                                                <div class=\"subtitle\">AI-Driven Diagnostic Algorithm<\/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=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">A digital health company sought CE marking under IVDR for their AI-powered diagnostic algorithm, with significant classification questions and limited clinical evidence.<\/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=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p><span style=\"font-weight: 400;\">MDx implemented a comprehensive regulatory strategy including:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Software classification guidance under IVDR rules<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">AI algorithm validation protocol development<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical performance study design specific to the algorithm&rsquo;s diagnostic claims<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Complete technical documentation aligned with IVDR Annex II and IEC 62304<\/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=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">Successful CE marking achieved under IVDR with minimal deficiencies, establishing a regulatory precedent for similar AI-based diagnostics.<\/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\/mobile-health-application-with-mdr-compliance\/\">\n                                                <div class=\"subtitle\">Mobile Health Application with MDR Compliance<\/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=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p><span style=\"font-weight: 400;\">A startup developed a mobile application for therapy adherence that qualified as a Class IIa medical device under MDR but lacked the internal regulatory expertise to navigate software requirements.<\/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=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p><span style=\"font-weight: 400;\">MDx delivered:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Complete IEC 62304 implementation and documentation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cybersecurity risk assessment and documentation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Usability engineering process aligned with IEC 62366<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical evaluation strategy based on real-world evidence collection<\/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=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p><span style=\"font-weight: 400;\">CE marking achieved in 11 months, enabling the client to launch in the European market ahead of competitors.<\/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<section id=\"block_fb2a1631e9cbe9b8fee6c5f7190ddbfa\" class=\"testimonials testimonials--grayscale\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-8.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/Untitled-8.jpg\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n                    <div class=\"headline\">T\u00e9moignages clients<\/div>\n        \n                    <div class=\"slider\">\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx&rsquo;s expertise in software medical device regulations was instrumental in our successful MDR submission. Their team understood both the technical aspects of our software and the regulatory requirements, bridging a gap that other consultants couldn&rsquo;t.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                CTO                                                                 <br>\n                                Digital Therapeutics Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0When developing our AI-based diagnostic solution, MDx provided invaluable guidance on clinical validation requirements specific to our algorithm. Their approach to documenting the AI system for regulatory review set us up for a smooth approval process.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Affairs Director                                                                 <br>\n                                AI Diagnostics Startup                                        \n                            <\/p>\n                                            <\/div>\n                            <\/div>\n        \n        <div class=\"footer\">\n            <div class=\"slider-dots\"><\/div>\n            <div class=\"button-wrapper\">\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_69ffbe6ad1c494b9a1311d1a89afc064\" 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\">Foire aux questions<\/h2>\n                          <a class=\"button button--default\" 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\">Comment les applications logicielles sont-elles class\u00e9es au titre du MDR et de l\u2019IVDR ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Sous le MDR et l\u2019IVDR, la classification des logiciels est d\u00e9termin\u00e9e via une \u00e9valuation compl\u00e8te qui prend en compte la finalit\u00e9 pr\u00e9vue du logiciel, ses fonctionnalit\u00e9s et son impact clinique, conform\u00e9ment aux derniers documents d\u2019orientation du MDCG. Pour le MDR, la r\u00e8gle 11 s\u2019applique principalement, classant les logiciels en classe I, IIa, IIb ou III selon le risque, notamment lorsque le logiciel fournit une aide \u00e0 la d\u00e9cision diagnostique ou th\u00e9rapeutique susceptible de causer un pr\u00e9judice grave ou irr\u00e9versible. Pour l\u2019IVDR, plusieurs r\u00e8gles peuvent s\u2019appliquer \u2014 comme la r\u00e8gle 1 pour les logiciels li\u00e9s aux maladies infectieuses \u00e0 haut risque (classe D), la r\u00e8gle 2 pour le sang et les affections mettant en jeu le pronostic vital (classes C ou D) et la r\u00e8gle 3 pour les tests g\u00e9n\u00e9tiques et les diagnostics compagnons (principalement classe C) \u2014 la classification d\u00e9pendant de l\u2019usage sp\u00e9cifique, de l\u2019influence sur le dispositif et du risque pour les patients ou la sant\u00e9 publique. Nos \u00e9valuations int\u00e8grent ces r\u00e8gles, ainsi que les orientations du MDCG (2019-11, 2021-24, 2019-16 et 2023-1), afin d\u2019assurer une classification pr\u00e9cise et le parcours r\u00e9glementaire appropri\u00e9.      <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelle documentation est requise pour la conformit\u00e9 \u00e0 l\u2019IEC 62304 ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La documentation IEC 62304 comprend les plans de d\u00e9veloppement logiciel, les dossiers de gestion des risques, la documentation d\u2019architecture et de conception d\u00e9taill\u00e9e, les protocoles\/rapports de v\u00e9rification et de validation, la documentation de r\u00e9solution des probl\u00e8mes et les plans de gestion de configuration logicielle. La documentation exacte d\u00e9pend de votre classification de s\u00e9curit\u00e9 logicielle (A, B ou C). MDx fournit des mod\u00e8les de documentation complets et un accompagnement au d\u00e9veloppement adapt\u00e9s \u00e0 la classe de risque sp\u00e9cifique de votre logiciel.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment valider les algorithmes IA\/ML pour l\u2019obtention d\u2019une autorisation r\u00e9glementaire ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\"> La validation des algorithmes IA\/ML n\u00e9cessite de d\u00e9montrer la performance, la robustesse et la s\u00e9curit\u00e9 au moyen de tests complets sur des jeux de donn\u00e9es diversifi\u00e9s, de m\u00e9triques de performance claires et de strat\u00e9gies d\u2019att\u00e9nuation des risques. Pour l\u2019obtention d\u2019une autorisation r\u00e9glementaire, vous avez besoin d\u2019une documentation sur la conception de l\u2019algorithme, les caract\u00e9ristiques des donn\u00e9es d\u2019entra\u00eenement, les m\u00e9triques de performance, les limites et les preuves de validation clinique. MDx d\u00e9veloppe des protocoles de validation sur mesure, sp\u00e9cifiques aux technologies d\u2019IA, qui r\u00e9pondent \u00e0 la fois aux exigences r\u00e9glementaires actuelles et aux r\u00e9glementations \u00e9mergentes sur l\u2019IA.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quel est l\u2019impact de l\u2019EU AI Act sur le d\u00e9veloppement de logiciels m\u00e9dicaux ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">L\u2019EU AI Act introduit des classifications et des exigences fond\u00e9es sur le risque pour les syst\u00e8mes d\u2019IA, l\u2019IA m\u00e9dicale relevant souvent de cat\u00e9gories \u00ab \u00e0 haut risque \u00bb n\u00e9cessitant une gestion des risques robuste, une gouvernance des donn\u00e9es et des mesures de transparence. Bien que l\u2019harmonisation avec le MDR\/IVDR soit en cours, les fabricants doivent se pr\u00e9parer \u00e0 une documentation suppl\u00e9mentaire, \u00e0 des tests et \u00e0 une surveillance post-commercialisation sp\u00e9cifiques aux composants d\u2019IA. MDx r\u00e9alise des analyses d\u2019\u00e9carts et propose des strat\u00e9gies de conformit\u00e9 afin d\u2019aligner vos processus de d\u00e9veloppement \u00e0 la fois sur les r\u00e9glementations relatives aux dispositifs m\u00e9dicaux et sur l\u2019AI Act.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Quelles preuves cliniques sont requises pour l\u2019approbation d\u2019un SaMD ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Les exigences en mati\u00e8re de preuves cliniques pour un SaMD d\u00e9pendent de sa classification et de ses all\u00e9gations, mais incluent g\u00e9n\u00e9ralement la d\u00e9monstration de la performance clinique (IVDR) ou du b\u00e9n\u00e9fice clinique (MDR), des performances dans la population cible et de la s\u00e9curit\u00e9 en utilisation clinique. Cela peut impliquer des revues de litt\u00e9rature, une validation analytique, des \u00e9tudes de performance clinique et\/ou des donn\u00e9es de performance en vie r\u00e9elle. MDx con\u00e7oit des strat\u00e9gies de preuves cliniques cibl\u00e9es, align\u00e9es sur le parcours r\u00e9glementaire et la classification de risque sp\u00e9cifiques de votre logiciel.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment g\u00e9rez-vous la surveillance post-commercialisation pour un logiciel faisant l\u2019objet de mises \u00e0 jour fr\u00e9quentes ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">La surveillance post-commercialisation des logiciels fr\u00e9quemment mis \u00e0 jour n\u00e9cessite un processus robuste de gestion des changements, une documentation claire des changements de version, des \u00e9valuations de significativit\u00e9 pour chaque mise \u00e0 jour, une surveillance continue des performances et des rapports de s\u00e9curit\u00e9 r\u00e9guliers. MDx d\u00e9veloppe des plans de PMS complets sp\u00e9cifiques aux produits logiciels, incluant des crit\u00e8res permettant de d\u00e9terminer quand des mises \u00e0 jour n\u00e9cessitent une notification r\u00e9glementaire ou une nouvelle \u00e9valuation de conformit\u00e9. <\/span><\/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\":\"Comment les applications logicielles sont-elles class\u00e9es au titre du MDR et de l\u2019IVDR ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Sous le MDR et l\u2019IVDR, la classification des logiciels est d\u00e9termin\u00e9e via une \u00e9valuation compl\u00e8te qui prend en compte la finalit\u00e9 pr\u00e9vue du logiciel, ses fonctionnalit\u00e9s et son impact clinique, conform\u00e9ment aux derniers documents d\u2019orientation du MDCG. Pour le MDR, la r\u00e8gle 11 s\u2019applique principalement, classant les logiciels en classe I, IIa, IIb ou III selon le risque, notamment lorsque le logiciel fournit une aide \u00e0 la d\u00e9cision diagnostique ou th\u00e9rapeutique susceptible de causer un pr\u00e9judice grave ou irr\u00e9versible. Pour l\u2019IVDR, plusieurs r\u00e8gles peuvent s\u2019appliquer \u2014 comme la r\u00e8gle 1 pour les logiciels li\u00e9s aux maladies infectieuses \u00e0 haut risque (classe D), la r\u00e8gle 2 pour le sang et les affections mettant en jeu le pronostic vital (classes C ou D) et la r\u00e8gle 3 pour les tests g\u00e9n\u00e9tiques et les diagnostics compagnons (principalement classe C) \u2014 la classification d\u00e9pendant de l\u2019usage sp\u00e9cifique, de l\u2019influence sur le dispositif et du risque pour les patients ou la sant\u00e9 publique. 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MDx fournit des mod\u00e8les de documentation complets et un accompagnement au d\u00e9veloppement adapt\u00e9s \u00e0 la classe de risque sp\u00e9cifique de votre logiciel.\"}},{\"@type\":\"Question\",\"name\":\"Comment valider les algorithmes IA\/ML pour l\u2019obtention d\u2019une autorisation r\u00e9glementaire ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La validation des algorithmes IA\/ML n\u00e9cessite de d\u00e9montrer la performance, la robustesse et la s\u00e9curit\u00e9 au moyen de tests complets sur des jeux de donn\u00e9es diversifi\u00e9s, de m\u00e9triques de performance claires et de strat\u00e9gies d\u2019att\u00e9nuation des risques. Pour l\u2019obtention d\u2019une autorisation r\u00e9glementaire, vous avez besoin d\u2019une documentation sur la conception de l\u2019algorithme, les caract\u00e9ristiques des donn\u00e9es d\u2019entra\u00eenement, les m\u00e9triques de performance, les limites et les preuves de validation clinique. MDx d\u00e9veloppe des protocoles de validation sur mesure, sp\u00e9cifiques aux technologies d\u2019IA, qui r\u00e9pondent \u00e0 la fois aux exigences r\u00e9glementaires actuelles et aux r\u00e9glementations \u00e9mergentes sur l\u2019IA.\"}},{\"@type\":\"Question\",\"name\":\"Quel est l\u2019impact de l\u2019EU AI Act sur le d\u00e9veloppement de logiciels m\u00e9dicaux ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"L\u2019EU AI Act introduit des classifications et des exigences fond\u00e9es sur le risque pour les syst\u00e8mes d\u2019IA, l\u2019IA m\u00e9dicale relevant souvent de cat\u00e9gories \u00ab \u00e0 haut risque \u00bb n\u00e9cessitant une gestion des risques robuste, une gouvernance des donn\u00e9es et des mesures de transparence. Bien que l\u2019harmonisation avec le MDR\/IVDR soit en cours, les fabricants doivent se pr\u00e9parer \u00e0 une documentation suppl\u00e9mentaire, \u00e0 des tests et \u00e0 une surveillance post-commercialisation sp\u00e9cifiques aux composants d\u2019IA. MDx r\u00e9alise des analyses d\u2019\u00e9carts et propose des strat\u00e9gies de conformit\u00e9 afin d\u2019aligner vos processus de d\u00e9veloppement \u00e0 la fois sur les r\u00e9glementations relatives aux dispositifs m\u00e9dicaux et sur l\u2019AI Act.\"}},{\"@type\":\"Question\",\"name\":\"Quelles preuves cliniques sont requises pour l\u2019approbation d\u2019un SaMD ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Les exigences en mati\u00e8re de preuves cliniques pour un SaMD d\u00e9pendent de sa classification et de ses all\u00e9gations, mais incluent g\u00e9n\u00e9ralement la d\u00e9monstration de la performance clinique (IVDR) ou du b\u00e9n\u00e9fice clinique (MDR), des performances dans la population cible et de la s\u00e9curit\u00e9 en utilisation clinique. Cela peut impliquer des revues de litt\u00e9rature, une validation analytique, des \u00e9tudes de performance clinique et\/ou des donn\u00e9es de performance en vie r\u00e9elle. MDx con\u00e7oit des strat\u00e9gies de preuves cliniques cibl\u00e9es, align\u00e9es sur le parcours r\u00e9glementaire et la classification de risque sp\u00e9cifiques de votre logiciel.\"}},{\"@type\":\"Question\",\"name\":\"Comment g\u00e9rez-vous la surveillance post-commercialisation pour un logiciel faisant l\u2019objet de mises \u00e0 jour fr\u00e9quentes ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"La surveillance post-commercialisation des logiciels fr\u00e9quemment mis \u00e0 jour n\u00e9cessite un processus robuste de gestion des changements, une documentation claire des changements de version, des \u00e9valuations de significativit\u00e9 pour chaque mise \u00e0 jour, une surveillance continue des performances et des rapports de s\u00e9curit\u00e9 r\u00e9guliers. MDx d\u00e9veloppe des plans de PMS complets sp\u00e9cifiques aux produits logiciels, incluant des crit\u00e8res permettant de d\u00e9terminer quand des mises \u00e0 jour n\u00e9cessitent une notification r\u00e9glementaire ou une nouvelle \u00e9valuation de conformit\u00e9.\"}}]}  <\/script>\n\n<section id=\"block_f8fc5395e07a442665bd6ede2e568ab8\" class=\"call-to-action\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n        <div class=\"call-to-action--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/mdx-cta-bg.png\" alt=\"\" \/>\n    <\/div>\n    <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"content\">\n                                    <h2 class=\"title\">Solutions r\u00e9glementaires logicielles expertes pour l\u2019innovation en sant\u00e9 num\u00e9rique<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\">Que vous d\u00e9veloppiez des diagnostics pilot\u00e9s par l\u2019IA, des applications de sant\u00e9 mobile ou des syst\u00e8mes SaMD complexes, MDx vous apporte l\u2019expertise r\u00e9glementaire sp\u00e9cialis\u00e9e dont vous avez besoin pour l\u2019acc\u00e8s aux march\u00e9s mondiaux et la conformit\u00e9.<\/span><\/p>\n<p><b>Naviguez dans l\u2019innovation num\u00e9rique. Atteignez la r\u00e9ussite r\u00e9glementaire. <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=software_dig_ai\" class=\"button button--tertiary\" target=\"\">\n                                R\u00e9server une \u00e9valuation r\u00e9glementaire logicielle                            <\/a>\n                                                                                                <a href=\"https:\/\/mdxcro.com\/samd-compliance-guide-navigating-regulations-for-software-as-a-medical-device\/\" class=\"button button--secondary\" target=\"\">\n                                Explorer notre guide de conformit\u00e9 SaMD                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n\n<script type=\"application\/ld+json\">{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Service\",\n  \"serviceType\": \"Software as Medical Device (SaMD) and AI Regulatory Services\",\n  \"provider\": {\n    \"@type\": \"Organization\",\n    \"name\": \"MDx CRO\",\n    \"url\": \"https:\/\/www.mdxcro.com\",\n    \"logo\": \"https:\/\/www.mdxcro.com\/wp-content\/uploads\/2025\/07\/MDX.svg\"\n  },\n  \"areaServed\": [\n    {\n      \"@type\": \"Place\",\n      \"name\": \"European Union\"\n    },\n    {\n      \"@type\": \"Place\", \n      \"name\": \"United States\"\n    },\n    {\n      \"@type\": \"Place\",\n      \"name\": \"Asia\"\n    }\n  ],\n  \"description\": \"Specialized regulatory services for Software as Medical Device (SaMD), digital health applications, and AI\/ML medical devices compliant with MDR\/IVDR, FDA guidance, and EU AI Act.\",\n  \"hasOfferCatalog\": {\n    \"@type\": \"OfferCatalog\",\n    \"name\": \"SaMD and AI Services\",\n    \"itemListElement\": [\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"SaMD Classification and Strategy\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"AI\/ML Clinical Validation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"EU AI Act Compliance\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Software Lifecycle Documentation\"\n        }\n      },\n      {\n        \"@type\": \"Offer\",\n        \"itemOffered\": {\n          \"@type\": \"Service\",\n          \"name\": \"Cybersecurity and Data Privacy\"\n        }\n      }\n    ]\n  }\n}\n<\/script>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-11855","service","type-service","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>Experts r\u00e9glementaires SaMD et sant\u00e9 num\u00e9rique | Conformit\u00e9 \u00e0 l\u2019AI Act<\/title>\n<meta name=\"description\" content=\"Accompagnement r\u00e9glementaire expert pour les logiciels en tant que dispositif m\u00e9dical (SaMD), la sant\u00e9 num\u00e9rique et les solutions bas\u00e9es sur l\u2019IA. 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