{"id":11084,"date":"2025-08-07T13:32:13","date_gmt":"2025-08-07T13:32:13","guid":{"rendered":"https:\/\/mdxcro.com\/services\/"},"modified":"2026-07-23T12:13:26","modified_gmt":"2026-07-23T12:13:26","slug":"services","status":"publish","type":"page","link":"https:\/\/mdxcro.com\/fr\/services\/","title":{"rendered":"Services"},"content":{"rendered":"\n<section id=\"block_88754c61e091c51f11581df8ca59539c\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2026\/04\/Services-MDx-CRO.webp\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Expertise compl\u00e8te en MedTech, diagnostics et sant\u00e9 num\u00e9rique<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\">D\u00e9couvrez notre portefeuille complet de services de CRO et de r\u00e9glementation par secteur. Des soumissions IVDR et MDR aux essais cliniques mondiaux et \u00e0 la conformit\u00e9 ISO, MDx offre une expertise transversale adapt\u00e9e \u00e0 votre technologie. <\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"#Precision-Medicine\" class=\"button button--default\" target=\"_self\">\n                            Explorer par secteur                        <\/a>\n                                            <a href=\"#Precision-Medicine\" class=\"button button--secondary\" target=\"_self\">\n                            Parcourir tous les services                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n\n<section id=\"block_8ad20254adcbc56e8c918d56f9be16ba\" 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=\"#Precision-Medicine\" class=\"link\" target=\"\"> \n                    M\u00e9decine de pr\u00e9cision \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#In-Vitro-Diagnostics\" class=\"link\" target=\"\"> \n                    Diagnostics in vitro \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Medical-Devices\" class=\"link\" target=\"\"> \n                    Dispositifs m\u00e9dicaux \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Software\" class=\"link\" target=\"\"> \n                    Logiciels, sant\u00e9 num\u00e9rique et IA \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Laboratories\" class=\"link\" target=\"\"> \n                    Laboratoires \n                <\/a>\n                            <\/ul>\n                \n    <\/div>\n<\/section>\n\n\n\n<section id=\"overview\" class=\"text-image text-image--smaller-title text-image--grayscale\" style=\"margin-top: var(--wp--preset--spacing--xxlarge); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">Que vous d\u00e9veloppiez un diagnostic bas\u00e9 sur l\u2019IA, que vous fassiez passer un test d\u00e9velopp\u00e9 en laboratoire sous IVDR, ou que vous lanciez un dispositif implantable de classe III, <span class=\"blue-highlight\"> MDx <\/span> offre \u00e0 la fois une <span class=\"blue-highlight\"> sp\u00e9cialisation verticale <\/span> et une <span class=\"blue-highlight\"> force transversale <\/span>. Parcourez par secteur pour voir ce que nous faisons dans votre domaine \u2014 ou explorez notre liste compl\u00e8te de services. <\/h2><\/div><\/div>                            <div class=\"column column--image\"><img decoding=\"async\" class=\"image\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Sectors-services-transversal-strenght-vertical-specialization.jpg\" alt=\"High-quality image of a person interacting with digital certification and approval icons on a laptop, emphasizing MedTech innovation, compliance, and accelerated medical technology solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n\n\n<section id=\"Precision-Medicine\" class=\"flip-cards flip-cards--four-columns flip-cards--grayscale \" style=\"margin-top: var(--wp--preset--spacing--xxlarge); \">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">M\u00e9decine de pr\u00e9cision et diagnostics compagnons <\/h2>\n            \n            \n                            <div class=\"description wysiwyg\"><p>Nous collaborons avec des d\u00e9veloppeurs de tests diagnostiques et des laboratoires pharmaceutiques pour commercialiser des produits CDx bas\u00e9s sur des biomarqueurs et d\u00e9velopp\u00e9s en partenariat.<\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-clinical-studies\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">\u00c9tudes cliniques IVD<\/div>\n                        <div class=\"back\"><p>Conception et ex\u00e9cution de protocoles pour les CDx selon l\u2019Annexe XIV de l\u2019IVDR, souvent int\u00e9gr\u00e9s dans des essais combin\u00e9s m\u00e9dicaments-diagnostics. Autorisation et notification PS. <\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/technical-documentation.jpg&#039;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Affaires r\u00e9glementaires et documentation technique<\/div>\n                        <div class=\"back\"><p>D\u00e9veloppement de toute la documentation technique du dispositif requise pour l\u2019autorisation d\u2019\u00e9tude de performance (PSA).<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-analytical-studies\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">\u00c9tudes analytiques IVD<\/div>\n                        <div class=\"back\"><p>Dossiers de validation analytique pour les dosages de biomarqueurs, les CDx bas\u00e9s sur le s\u00e9quen\u00e7age et les immunoessais.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/representative-services\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Services de repr\u00e9sentation<\/div>\n                        <div class=\"back\"><p>Soutien du repr\u00e9sentant l\u00e9gal pour les \u00e9tudes de performance CDx sous IVDR dans l\u2019UE et services de RP au Royaume-Uni.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/sectors\/laboratories\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Solutions de laboratoire<\/div>\n                        <div class=\"back\"><p>\u00c9valuation de l\u2019exemption des \u00e9tablissements de sant\u00e9 de l\u2019UE en vertu de l\u2019article 5, paragraphe 5, et diligence raisonnable des tests locaux.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/services-ngs\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Services NGS et bioinformatiques<\/div>\n                        <div class=\"back\"><p>Validation des pipelines bioinformatiques pour le NGS, le profilage tumoral, les diagnostics germinaux et plus encore.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/scientific-validity-scaled.jpeg&#039;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/rapports-de-validite-scientifique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Rapports de validit\u00e9 scientifique<\/div>\n                        <div class=\"back\"><p>\u00c9valuations de l\u2019utilit\u00e9 clinique bas\u00e9es sur la litt\u00e9rature pour le lien entre le biomarqueur et la th\u00e9rapie cibl\u00e9e.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/formation-conseil\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Formation et conseil<\/div>\n                        <div class=\"back\"><p>Pr\u00e9paration r\u00e9glementaire des CDx, formation aux \u00e9tudes de performance et planification collaborative avec les entreprises pharmaceutiques sous IVDR.<\/p>\n<\/div>\n                    <\/a>\n                            <\/div>\n        \n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/services\/precision-medicine-companion-diagnostics\/\" class=\"button button--default\" target=\"_self\">\n                        Explorer les solutions de m\u00e9decine de pr\u00e9cision                    <\/a>\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/domaines-therapeutiques\/\" class=\"button button--quaternary\" target=\"_self\">\n                        Explorer nos domaines th\u00e9rapeutiques                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n<section id=\"In-Vitro-Diagnostics\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale flip-cards--card-size-extra-small \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Diagnostics in vitro (IVD)<\/h2>\n            \n            \n                            <div class=\"description wysiwyg\"><p>Nous accompagnons les d\u00e9veloppeurs de dispositifs de diagnostic in vitro (IVD) en leur proposant des solutions compl\u00e8tes, depuis la validation RUO jusqu&rsquo;au marquage CE au titre du r\u00e8glement IVDR et aux demandes d&rsquo;autorisation 510(k) ou De Novo aupr\u00e8s de la FDA.<\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-analytical-studies\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">\u00c9tudes analytiques IVD<\/div>\n                        <div class=\"back\"><p>V\u00e9rification analytique et rapports de performance conformes au CLSI.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ivd-clinical-studies\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">\u00c9tudes cliniques IVD<\/div>\n                        <div class=\"back\"><p>Conception et ex\u00e9cution d\u2019\u00e9valuations de performance conformes \u00e0 la norme ISO 20916 sous IVDR.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/rapports-de-validite-scientifique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Rapports de validit\u00e9 scientifique<\/div>\n                        <div class=\"back\"><p>G\u00e9n\u00e9ration de preuves align\u00e9e sur l\u2019Annexe XIII avec recherche bibliographique assist\u00e9e par l\u2019IA.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Affaires r\u00e9glementaires et documentation technique<\/div>\n                        <div class=\"back\"><p>Listes de contr\u00f4le GSPR, PER et cr\u00e9ation compl\u00e8te de dossiers techniques IVDR.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/services-ngs\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Services NGS et bioinformatiques<\/div>\n                        <div class=\"back\"><p>Validation des dosages multiplex, des flux de travail de s\u00e9quen\u00e7age et des pipelines de donn\u00e9es dans des contextes IVD r\u00e9glement\u00e9s.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ingenierie-de-l-aptitude-a-l-utilisation\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Ing\u00e9nierie de l\u2019aptitude \u00e0 l\u2019utilisation<\/div>\n                        <div class=\"back\"><p>Validation des facteurs humains pour les tests au chevet du patient et les interactions entre les instruments et les utilisateurs dans le cadre du r\u00e8glement IVDR.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/audit-risques-qualite\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Qualit\u00e9, risque et audit<\/div>\n                        <div class=\"back\"><p>D\u00e9veloppement de SMQ conforme \u00e0 l\u2019IVDR, mise en \u0153uvre de l\u2019ISO 13485, gestion des risques selon l\u2019ISO 14971 et audits internes.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/representative-services\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Services de repr\u00e9sentation<\/div>\n                        <div class=\"back\"><p>Repr\u00e9sentation l\u00e9gale AR UE, UKRP et IVDR pour les \u00e9tudes de performance.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/formation-conseil\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Formation et conseil<\/div>\n                        <div class=\"back\"><p>Mise en \u0153uvre de l\u2019IVDR, SMQ et pr\u00e9paration \u00e0 l\u2019organisme notifi\u00e9.<\/p>\n<\/div>\n                    <\/a>\n                            <\/div>\n        \n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/sectors\/ivd-end-to-end\/\" class=\"button button--tertiary\" target=\"_self\">\n                        Explorer les solutions IVD                    <\/a>\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/domaines-therapeutiques\/\" class=\"button button--secondary\" target=\"_self\">\n                        Explorer nos domaines th\u00e9rapeutiques                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n<section id=\"Medical-Devices\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Dispositifs m\u00e9dicaux<\/h2>\n            \n            \n                            <div class=\"description wysiwyg\"><p><span style=\"font-weight: 400;\">Nous aidons les fabricants \u00e0 r\u00e9pondre aux attentes du MDR et de la FDA gr\u00e2ce \u00e0 la validation clinique, \u00e0 la documentation et \u00e0 l\u2019ing\u00e9nierie de l\u2019utilisabilit\u00e9.<\/span><\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/solutions-cliniques-medtech\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Solutions cliniques MedTech<\/div>\n                        <div class=\"back\"><p>Essais conformes \u00e0 l\u2019ISO 14155, PMCF et gestion de sites mondiaux.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ingenierie-de-l-aptitude-a-l-utilisation\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Ing\u00e9nierie de l\u2019aptitude \u00e0 l\u2019utilisation<\/div>\n                        <div class=\"back\"><p>Validation des facteurs humains conforme \u00e0 l\u2019IEC 62366 pour les dispositifs de classe I \u00e0 III.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Affaires r\u00e9glementaires et documentation technique<\/div>\n                        <div class=\"back\"><p>Rem\u00e9diation CER, pr\u00e9paration des dossiers MDR Annexe II\/III et conformit\u00e9 de l\u2019\u00e9tiquetage.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/quality-risk-audit.jpg&#039;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/audit-risques-qualite\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Qualit\u00e9, risque et audit<\/div>\n                        <div class=\"back\"><p>Gestion des risques selon l\u2019ISO 14971, audits ISO 13485 et syst\u00e8mes CAPA.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/representative-services\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Services de repr\u00e9sentation<\/div>\n                        <div class=\"back\"><p>Repr\u00e9sentation MDR et responsabilit\u00e9s UKRP pour les fabricants non-UE\/Royaume-Uni.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/trainning-consultancy.jpg&#039;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/formation-conseil\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Formation et conseil<\/div>\n                        <div class=\"back\"><p>Ateliers sur la pr\u00e9paration au MDR, les attentes des organismes notifi\u00e9s, les preuves cliniques et la mise en \u0153uvre de l\u2019ISO 13485.<\/p>\n<\/div>\n                    <\/a>\n                            <\/div>\n        \n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/sectors\/medical-devices\/\" class=\"button button--default\" target=\"_self\">\n                        Explorer les solutions pour dispositifs m\u00e9dicaux                     <\/a>\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/domaines-therapeutiques\/\" class=\"button button--quaternary\" target=\"_self\">\n                        Explorer nos domaines th\u00e9rapeutiques                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n<section id=\"Software\" class=\"flip-cards flip-cards--four-columns flip-cards--grayscale flip-cards--bg-blue\" style=\"\">\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\/09\/Vector-1.png\" alt=\"\" \/>\n\t<\/div>\n\t    <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Logiciels, sant\u00e9 num\u00e9rique et IA<\/h2>\n            \n            \n                            <div class=\"description wysiwyg\"><p><span style=\"font-weight: 400;\">Des SaMD et diagnostics connect\u00e9s aux outils d\u2019IA\/ML, nous soutenons la conformit\u00e9 de bout en bout en mati\u00e8re de sant\u00e9 num\u00e9rique sous MDR, IVDR et la future loi sur l\u2019IA.<\/span><\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/ingenierie-de-l-aptitude-a-l-utilisation\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Ing\u00e9nierie de l\u2019aptitude \u00e0 l\u2019utilisation<\/div>\n                        <div class=\"back\"><p>Tests des facteurs humains pour les applications mobiles, les dispositifs portables et les interfaces.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Affaires r\u00e9glementaires et documentation technique<\/div>\n                        <div class=\"back\"><p>Documentation IEC 62304, classification des risques et voies CE\/FDA.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/c09b57f3ff74a76f185f5cd949ca1825498d2359.jpg&#039;);\"                         href=\"https:\/\/mdxcro.com\/fr\/services\/formation-conseil\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Formation et conseil<\/div>\n                        <div class=\"back\"><p>R\u00e9glementation de l\u2019IA, directives SaMD et alignement du cadre de cybers\u00e9curit\u00e9.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/solutions-cliniques-medtech\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Solutions cliniques MedTech<\/div>\n                        <div class=\"back\"><p>Validation clinique des th\u00e9rapies num\u00e9riques et des diagnostics IA, y compris la g\u00e9n\u00e9ration de preuves et la supervision des essais pour les produits logiciels r\u00e9glement\u00e9s.<\/p>\n<\/div>\n                    <\/a>\n                            <\/div>\n        \n                    <div class=\"button-wrapper\">\n                                    <a href=\"https:\/\/mdxcro.com\/fr\/services\/logiciel-sante-numerique-ia\/\" class=\"button button--tertiary\" target=\"_self\">\n                        Explorer les solutions de sant\u00e9 num\u00e9rique                    <\/a>\n                            <\/div>\n            <\/div>\n<\/section>\n\n\n<section id=\"Laboratories\" class=\"flip-cards flip-cards--four-columns flip-cards--grayscale \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Laboratoires<\/h2>\n            \n            \n                            <div class=\"description wysiwyg\"><p><span style=\"font-weight: 400;\">Nous aidons les laboratoires hospitaliers, de r\u00e9f\u00e9rence et cliniques \u00e0 se conformer \u00e0 l&rsquo;article 5.5 du r\u00e8glement IVDR et \u00e0 la norme ISO 15189, tout en validant leurs tests internes et en garantissant leur conformit\u00e9 aux normes internationales.<\/span><\/p>\n<\/div>\n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <a class=\"card card--background-blue\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/affaires-reglementaires-documentation-technique\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Affaires r\u00e9glementaires et documentation technique<\/div>\n                        <div class=\"back\"><p>R\u00e9daction de la documentation technique relative aux tests internes, y compris les dossiers de justification, les listes de contr\u00f4le GSPR et les d\u00e9clarations publiques au titre de l&rsquo;article 5.5 et du r\u00e8glement IVDR<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-black\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/audit-risques-qualite\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Qualit\u00e9, risque et audit<\/div>\n                        <div class=\"back\"><p>D\u00e9veloppement de SMQ hybride combinant les normes ISO 15189 et ISO 13485, pr\u00e9paration \u00e0 l\u2019audit et conception de processus bas\u00e9s sur les risques.<\/p>\n<\/div>\n                    <\/a>\n                                    <a class=\"card card--background-white\"\n                                                  href=\"https:\/\/mdxcro.com\/fr\/services\/formation-conseil\/\" target=\"\">\n                        \n                                                                            \n                        <div class=\"front\">Formation et conseil<\/div>\n                        <div class=\"back\"><p>Ateliers de conformit\u00e9 \u00e0 l\u2019article 5.5 de l\u2019IVDR, \u00e9valuations des lacunes de l\u2019ISO 15189 et harmonisation des SOP pour les laboratoires cliniques.<\/p>\n<\/div>\n                    <\/a>\n                                    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Tous les secteurs. Prestation de services compl\u00e8te.  <\/h3>\n        \n                  <div class=\"description wysiwyg\">\n            <ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Approuv\u00e9 par les 10 plus grandes entreprises d\u2019IVD, pharmaceutiques et MedTech<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">100 % d\u2019approbations de marquage CE du premier coup<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Partenaire de formation privil\u00e9gi\u00e9 des principaux organismes notifi\u00e9s de l\u2019UE sur l\u2019IVDR\/MDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Sp\u00e9cialistes en IVDR, MDR, ISO 13485\/15189 et SaMD<\/span><\/li>\n<\/ul>\n          <\/div>\n              <\/div>\n\n          <\/div>\n\n          <div class=\"button-wrapper\">\n                  <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=services_page\" class=\"button button--tertiary\" target=\"\">\n            R\u00e9server un appel de d\u00e9couverte          <\/a>\n                  <a href=\"https:\/\/mdxcro.com\/fr\/secteurs\/\" class=\"button button--secondary\" target=\"\">\n            Explorer les secteurs          <\/a>\n              <\/div>\n      <\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-11084","page","type-page","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>Validation NGS et services de conformit\u00e9 IVDR | R\u00e9glementation et CRO<\/title>\n<meta name=\"description\" content=\"Validation NGS de bout en bout, conformit\u00e9 des pipelines bioinformatiques (IEC 62304) et marquage CE IVDR. 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