{"id":11858,"date":"2025-09-10T15:10:54","date_gmt":"2025-09-10T15:10:54","guid":{"rendered":"https:\/\/mdxcro.com\/services\/audit-risques-qualite\/"},"modified":"2026-06-24T09:49:34","modified_gmt":"2026-06-24T09:49:34","slug":"audit-risques-qualite","status":"publish","type":"service","link":"https:\/\/mdxcro.com\/fr\/services\/audit-risques-qualite\/","title":{"rendered":"Qualit\u00e9, risque et audit"},"content":{"rendered":"\n<section id=\"block_40fc2da5fd4a4633942eb812d84df6a2\" class=\"hero\">\n    <div class=\"hero--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/quality-hero.jpg\" fetchpriority=\"high\" class=\"no-lazy\" alt=\"\" \/>\n    <\/div>\n        <div class=\"container\">\n                <div class=\"content\">\n                                    <h1 class=\"title\">Des syst\u00e8mes qualit\u00e9 et une gestion des risques qui favorisent la r\u00e9ussite r\u00e9glementaire<\/h1>\n            \n                            <div class=\"description\"><p><span style=\"font-weight: 400;\" data-mce-style=\"font-weight: 400;\">De la mise en \u0153uvre de l\u2019ISO 13485 et de la gestion des risques \u00e0 la pr\u00e9paration compl\u00e8te des audits, nos anciens auditeurs d\u2019organismes notifi\u00e9s fournissent des solutions qualit\u00e9 et conformit\u00e9 capables de r\u00e9sister \u00e0 l\u2019examen r\u00e9glementaire le plus rigoureux, pour les DIV comme pour les dispositifs m\u00e9dicaux.<\/span><\/p>\n<\/div>\n            \n                            <div class=\"button-wrapper\">\n                                            <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=qty_risk_audit\" class=\"button bouton--par d\u00e9faut\" target=\"_self\">\n                            R\u00e9server une \u00e9valuation qualit\u00e9                        <\/a>\n                                            <a href=\"https:\/\/mdxcro.com\/iso-13485-implementation-guide\/\" class=\"button bouton--secondaire\" target=\"_self\">\n                            Acc\u00e9der \u00e0 notre guide de mise en \u0153uvre du SMQ                        <\/a>\n                                    <\/div>\n                            <\/div>\n            <\/div>\n<\/section>\n\n<section id=\"block_9dcc361b56bae427b736d73d88fdbbbd\" class=\"text-image\" style=\"padding-top: var(--wp--preset--spacing--medium); padding-bottom: var(--wp--preset--spacing--large); \">\n        <div class=\"container\">\n        <div class=\"grid\">\n            <div class=\"column column--content\"><div class=\"text\"><h2 class=\"title\">L\u2019excellence qualit\u00e9 pour les dispositifs m\u00e9dicaux et les DIV<\/h2><div class=\"description wysiwyg\"><p><span style=\"font-weight: 400\">Dans l\u2019environnement r\u00e9glementaire rigoureux d\u2019aujourd\u2019hui, des syst\u00e8mes qualit\u00e9 robustes et une gestion approfondie des risques sont incontournables pour les fabricants de dispositifs m\u00e9dicaux et de DIV. MDx propose des services complets de qualit\u00e9, de gestion des risques et d\u2019audit, con\u00e7us pour s\u00e9curiser et maintenir la conformit\u00e9 tout en optimisant votre efficacit\u00e9 op\u00e9rationnelle. <\/span><\/p>\n<p><span style=\"font-weight: 400\">Notre \u00e9quipe \u2014 compos\u00e9e d\u2019anciens auditeurs d\u2019organismes notifi\u00e9s et d\u2019experts qualit\u00e9 issus de fabricants de premier plan \u2014 fournit des solutions pratiques et \u00e9volutives, adapt\u00e9es \u00e0 vos technologies sp\u00e9cifiques, \u00e0 vos besoins organisationnels et \u00e0 vos exigences r\u00e9glementaires. Que vous mettiez en \u0153uvre l\u2019ISO 13485 pour la premi\u00e8re fois, que vous passiez au MDR\/IVDR ou que vous pr\u00e9pariez un audit \u00e0 forts enjeux, MDx veille \u00e0 ce que vos syst\u00e8mes qualit\u00e9 r\u00e9pondent \u00e0 la fois aux exigences r\u00e9glementaires et \u00e0 vos objectifs business. <\/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\/Untitled-scaled.jpeg\" alt=\"Advanced medical research with computer analysis for medtech innovation and healthcare solutions.\"  \/><\/div>                    <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_51603c31a64dcf08fedfdd00cd1a4547\" 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=\"#QMS\" class=\"link\" target=\"\"> \n                    SMQ \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Risk-Management\" class=\"link\" target=\"\"> \n                    Gestion des risques \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#Audit-Services\" class=\"link\" target=\"\"> \n                    Services d\u2019audit \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#PRRC\" class=\"link\" target=\"\"> \n                    PRRC \n                <\/a>\n                                <li class=\"item\">\n                            <a href=\"#V&#038;V\" class=\"link\" target=\"\"> \n                    V&amp;V \n                <\/a>\n                            <\/ul>\n                \n    <\/div>\n<\/section>\n\n<section id=\"QMS\" class=\"flip-cards flip-cards--three-columns \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Services cl\u00e9s en qualit\u00e9, risques et audit<\/h2>\n            \n                            <div class=\"teaser wysiwyg\"><p><b>Syst\u00e8mes de management de la qualit\u00e9<\/b><\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Mise en \u0153uvre et certification ISO 13485:2016<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuations des \u00e9carts par rapport aux exigences actuelles<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement complet du SMQ pour les startups et les PME<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification et ex\u00e9cution de la mise en \u0153uvre<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement de la documentation (manuel qualit\u00e9, SOP, instructions de travail)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Conseil et support au repr\u00e9sentant de la direction<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Pr\u00e9paration \u00e0 l\u2019audit de pr\u00e9-certification<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">S\u00e9lection de l\u2019organisme notifi\u00e9 et de l\u2019organisme de certification<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Rem\u00e9diation et optimisation du SMQ<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Alignement MDSAP, EU MDR\/IVDR et FDA QSR<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Cartographie et optimisation des processus<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Mise en \u0153uvre d\u2019un syst\u00e8me de ma\u00eetrise des documents<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Solutions de gestion des enregistrements qualit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement et am\u00e9lioration des syst\u00e8mes CAPA<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Contr\u00f4les qualit\u00e9 sp\u00e9cifiques aux DIV et adaptations du SMQ<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Indicateurs de performance du SMQ et reporting<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Gestion et support int\u00e9rimaires du SMQ<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Leadership qualit\u00e9 temporaire pendant les transitions<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Offres de support AQ \u00e0 distance<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Solutions d\u2019\u00e9quipe qualit\u00e9 virtuelle<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Mise en place du service AQ pour les startups<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Formation du personnel qualit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Support et facilitation des revues de direction<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"Risk-Management\" class=\"flip-cards flip-cards--has-bg-image flip-cards--three-columns \" style=\"\">\n                <div class=\"flip-cards--bg\">\n                <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/testimonials-bg.jpg\" alt=\"\" \/>\n            <\/div>\n                    <div class=\"container\">\n        <div class=\"content\">\n            \n            \n                            <div class=\"teaser wysiwyg\"><p><b>Gestion des risques<\/b><\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--background-blue\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Mise en \u0153uvre de l\u2019ISO 14971:2019<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification de la gestion des risques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement du dossier de gestion des risques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Surveillance des risques en production et post-production<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Documentation de l\u2019analyse b\u00e9n\u00e9fice\/risque<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Ateliers d\u2019identification des dangers<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Approches de gestion des risques sp\u00e9cifiques aux dispositifs et aux DIV<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Documentation de gestion des risques<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Plans de gestion des risques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Rapports de gestion des risques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Analyse des risques avec FTA, FMEA, HAZOP<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">D\u00e9veloppement de la FMEA processus (pFMEA)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Cr\u00e9ation de la FMEA conception (dFMEA)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuations des risques d\u2019utilisabilit\u00e9 (IEC 62366)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Gestion des risques de cybers\u00e9curit\u00e9 (IEC 80001)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Gestion des risques sp\u00e9cifique aux DIV (p. ex., faux r\u00e9sultats, impact clinique)<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Int\u00e9gration de la gestion des risques<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Int\u00e9gration avec l\u2019\u00e9valuation clinique\/l\u2019\u00e9valuation des performances<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Alignement avec l\u2019ing\u00e9nierie de l\u2019utilisabilit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Int\u00e9gration des donn\u00e9es de risque PMS\/PMCF\/PMPF<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><a href=\"https:\/\/mdxcro.com\/sectors\/software-digital-health-ai\/\"><span style=\"font-weight: 400;\">Gestion des risques logiciels (IEC 62304)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuations des risques de biocompatibilit\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Ma\u00eetrises des risques pour proc\u00e9d\u00e9s sp\u00e9ciaux<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Approches bas\u00e9es sur les risques pour le CQ et la lib\u00e9ration de lots des DIV<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"Audit-Services\" class=\"flip-cards flip-cards--three-columns \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n            \n                            <div class=\"teaser wysiwyg\"><p><b>Services d\u2019audit<\/b><\/p>\n<\/div>\n            \n                    <\/div>\n\n                    <div class=\"grid\">\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2023\/05\/shutterstock_245479591-scaled-1.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Audits internes<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits de conformit\u00e9 ISO 13485<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuations de pr\u00e9paration MDR\/IVDR<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits internes MDSAP<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits de processus<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">R\u00e9alisation d\u2019audits \u00e0 distance et hybrides<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits de proc\u00e9d\u00e9s sp\u00e9ciaux<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits de d\u00e9veloppement logiciel<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><a href=\"https:\/\/mdxcro.com\/sectors\/laboratories\/\"><span style=\"font-weight: 400;\">Audits des processus de laboratoire (ISO 15189)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Rapports d\u2019audit complets avec plans de rem\u00e9diation<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white\"\n                                                  >\n                        \n                                                                            \n                        <div class=\"front\">Audits des fournisseurs et sous-traitants<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Qualification des fournisseurs critiques<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits OEM<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">\u00c9valuation des fournisseurs internationaux<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Programmes d\u2019audit fournisseurs \u00e0 distance<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Syst\u00e8mes de classification et de surveillance des fournisseurs<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits des fournisseurs de composants (pour dispositifs et DIV)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Audits des fournisseurs de laboratoire<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/trainning-consultancy.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\">Pr\u00e9paration et gestion des audits<\/div>\n                        <div class=\"back\"><ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Pr\u00e9paration aux audits d\u2019organisme notifi\u00e9<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Pr\u00e9paration aux inspections FDA<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Planification des audits MDSAP<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Inspections simul\u00e9es et mises en situation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Gestion des r\u00e9ponses aux audits<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Rem\u00e9diation des constats d\u2019audit<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Support lors des inspections des autorit\u00e9s comp\u00e9tentes<\/span><\/li>\n<\/ul>\n<\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"PRRC\" class=\"content-columns content-columns--three-columns content-columns--background-white\" style=\"padding-top: var(--wp--preset--spacing--large); padding-bottom: var(--wp--preset--spacing--regular); \">\n    \t<div \n\t\tclass=\"component-top-icon\"\n\t\tstyle=\"--component-top-icon-height: 70px\"\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                                    <h2 class=\"title\">Services sp\u00e9cialis\u00e9s en qualit\u00e9 et conformit\u00e9<\/h2>\n                                                    <div class=\"description wysiwyg\">\n                        <p><b>Exigences r\u00e9glementaires pour les dispositifs m\u00e9dicaux et les DIV<\/b><\/p>\n                    <\/div>\n                            <\/div>\n        \n                    <div class=\"grid\">\n                                                        <div class=\"card card--background-black\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Personne responsable de la conformit\u00e9 r\u00e9glementaire (PRRC)<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Services d\u2019externalisation PRRC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9veloppement d\u2019une \u00e9quipe PRRC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Gestion et d\u00e9l\u00e9gation des responsabilit\u00e9s<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation des activit\u00e9s PRRC<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Formation des candidats PRRC internes<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                                            <div class=\"card card--background-white-frost\">\n                                            <div class=\"top\">\n                                                                                        <h3 class=\"headline\">Conformit\u00e9 qualit\u00e9 MDR\/IVDR<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Mises \u00e0 jour du SMQ pour les exigences MDR\/IVDR<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Planification de la transition et analyse des \u00e9carts<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Int\u00e9gration du syst\u00e8me de surveillance post-commercialisation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Mise en \u0153uvre de l\u2019UDI et d\u2019EUDAMED<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Exigences relatives aux op\u00e9rateurs \u00e9conomiques<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Exigences qualit\u00e9 sp\u00e9cifiques aux DIV (lib\u00e9ration de lots, CQ des r\u00e9actifs)<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n\n<section id=\"V&amp;V\" class=\"content-columns content-columns--three-columns \" style=\"padding-top: var(--wp--preset--spacing--regular); padding-bottom: var(--wp--preset--spacing--large); \">\n        <div class=\"container\">\n                    <div class=\"content\">\n                                                    <div class=\"description wysiwyg\">\n                        <p><b>Validation et v\u00e9rification<\/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\">V\u00e9rification et validation de la conception<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Planification et ex\u00e9cution de la V&#038;V<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9veloppement de protocoles<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation des m\u00e9thodes d\u2019essai<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Documentation pour le dossier d\u2019historique de conception<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation des performances analytiques des DIV<\/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\">Validation des proc\u00e9d\u00e9s<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">D\u00e9veloppement de protocoles IQ\/OQ\/PQ<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation des proc\u00e9d\u00e9s sp\u00e9ciaux<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation du nettoyage<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation logicielle<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation de feuilles de calcul<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Analyse statistique et support<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation des proc\u00e9d\u00e9s de fabrication pour les DIV<\/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\">Validation des syst\u00e8mes informatis\u00e9s<\/h3>\n                                                                                        <div class=\"teaser wysiwyg\"><ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Mise en \u0153uvre de la m\u00e9thodologie GAMP 5<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Conformit\u00e9 des enregistrements \u00e9lectroniques (21 CFR Part 11)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation ERP et eQMS<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Qualification des syst\u00e8mes cloud<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Validation des syst\u00e8mes d\u2019information de laboratoire<\/span><\/li>\n<\/ul>\n<\/div>\n                                                    <\/div>\n                                                                    <\/div>\n                                                <\/div>\n                  \n          \n\n            <\/div>\n<\/section>\n<section class=\"table\"><div class=\"container\"><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>Anciens auditeurs d\u2019organismes notifi\u00e9s<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Exp\u00e9rience sectorielle<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Expertise combin\u00e9e dispositifs et DIV<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Approche pratique<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Services int\u00e9gr\u00e9s<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Exp\u00e9rience des audits simul\u00e9s<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Mod\u00e8les sp\u00e9cifiques \u00e0 la technologie<\/strong><\/td><\/tr><tr><td class=\"feature-cell\"><strong>Solutions \u00e0 la bonne dimension<\/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=\"\">De BSI, T\u00dcV S\u00dcD<\/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=\"\">Rarement disponibles<\/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=\"\">Experts issus des 10 premiers fabricants de DIV et de dispositifs<\/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=\"\">Souvent uniquement des connaissances th\u00e9oriques<\/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=\"\">Sp\u00e9cialistes des deux cadres r\u00e9glementaires<\/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=\"\">G\u00e9n\u00e9ralement ax\u00e9s sur un seul domaine<\/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=\"\">Solutions de conformit\u00e9 orient\u00e9es business<\/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=\"\">Conformit\u00e9 au d\u00e9triment de l\u2019efficacit\u00e9<\/td><\/tr><tr><td class=\"cell highlight\"><img decoding=\"async\" width=\"40\" height=\"40\" class=\"wp-image-6695 icon\" style=\"width: 40px;\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Tick-copy.svg\" alt=\"\">Qualit\u00e9 + R\u00e9glementaire + Clinique<\/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=\"\">G\u00e9n\u00e9ralement une seule sp\u00e9cialit\u00e9<\/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=\"\">Sc\u00e9narios r\u00e9alistes NB\/FDA<\/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=\"\">\u00c9valuations 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=\"\">Pour les DIV, les dispositifs, les logiciels<\/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=\"\">Mod\u00e8les 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=\"\">Adapt\u00e9es \u00e0 la maturit\u00e9 et aux ressources de l\u2019entreprise<\/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=\"\">Approche unique pour tous<\/td><\/tr><\/tbody><\/table><\/div><\/div><\/div><\/section>\n<section class=\"key-stats\"  style=\"\">\n  \t<div \n\t\tclass=\"component-top-icon\"\n\t\tstyle=\"--component-top-icon-height: 70px\"\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=\"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\">100+<\/div>\n                                                  <div class=\"legend\">certifications ISO 13485 r\u00e9ussies<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">97%<\/div>\n                                                  <div class=\"legend\">taux de r\u00e9ussite \u00e0 la premi\u00e8re certification<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">85%<\/div>\n                                                  <div class=\"legend\">r\u00e9duction des constats majeurs d\u2019audit apr\u00e8s rem\u00e9diation MDx<\/div>\n                              <\/div>\n                                                <div class=\"box\">\n                                  <div class=\"value\">40+<\/div>\n                                                  <div class=\"legend\">entreprises passant aux exigences qualit\u00e9 MDR\/IVDR<\/div>\n                              <\/div>\n                              <\/div>\n      \n          <\/div>\n\n    <div class=\"data\">\n              <div class=\"description wysiwyg\">\n          <p><b>Anciens auditeurs BSI, T\u00dcV S\u00dcD<\/b><span style=\"font-weight: 400\"> au sein de l\u2019\u00e9quipe<\/span><\/p>\n<p><b>Z\u00e9ro constat<\/b><span style=\"font-weight: 400\"> majeur lors de nos 10 derniers audits de syst\u00e8me qualit\u00e9 sp\u00e9cifiques \u00e0 l\u2019IVDR<\/span><\/p>\n<p><strong>Gestion des risques ISO 14971 de bout en bout<\/strong> (RMF) r\u00e9alis\u00e9e et align\u00e9e sur les attentes des organismes notifi\u00e9s<\/p>\n        <\/div>\n      \n          <\/div>\n  <\/div>\n<\/section>\n\n<section id=\"block_a91a1fdc92840466de3ecc6404fbd79f\" class=\"flip-cards flip-cards--three-columns flip-cards--grayscale flip-cards--card-size-small \" style=\"\">\n            <div class=\"container\">\n        <div class=\"content\">\n            \n                            <h2 class=\"title\">Notre processus de gestion de la qualit\u00e9 et des risques<\/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<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Revue compl\u00e8te des syst\u00e8mes, de la documentation et des pratiques existants<\/span><\/p>\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\">Analyse des \u00e9carts<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Identification des \u00e9carts de conformit\u00e9 par rapport aux normes et r\u00e9glementations pertinentes<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/Untitled-46.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">3.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Planification strat\u00e9gique<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">\u00c9laboration d\u2019une feuille de route prioris\u00e9e de mise en \u0153uvre ou de rem\u00e9diation<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--value\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/07\/technical-doc.jpg&#039;);\"                         >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">4.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Documentation<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Cr\u00e9ation ou r\u00e9vision de la documentation du syst\u00e8me qualit\u00e9<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-black card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">5.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Mise en \u0153uvre<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Ex\u00e9cution pratique des processus qualit\u00e9 et de la gestion des risques<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-blue card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">6.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">V\u00e9rification<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Audits internes et \u00e9valuations de pr\u00e9-certification<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">7.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Support \u00e0 la certification<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Accompagnement expert tout au long des audits de certification<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--background-white card--value\"\n                                                  >\n                        \n                                                                                    <div class=\"circle\">\n                                    <div class=\"value\">8.<\/div>\n                                <\/div>\n                                                    \n                        <div class=\"front\">Am\u00e9lioration continue<\/div>\n                        <div class=\"back\"><p><span style=\"font-weight: 400;\">Surveillance continue et optimisation des syst\u00e8mes qualit\u00e9<\/span><\/p>\n<\/div>\n                    <\/div>\n                                    <div class=\"card card--has-bg-image card--image-only\"\n                         style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/logo-rectangle-black.jpg&#039;);\"                         >\n                        \n                                                                            \n                        <div class=\"front\"><\/div>\n                        <div class=\"back\"><\/div>\n                    <\/div>\n                            <\/div>\n        \n            <\/div>\n<\/section>\n<section id=\"block_d06f47d7d0ee378cad53cebc86ad62e1\" class=\"case-study-details\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/09\/software-ivd.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\/so-13485-implementation-for-precision-medicine-startup\/\">\n                                                <div class=\"subtitle\">ISO 13485 Implementation for Precision Medicine Startup<\/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>A precision medicine startup with limited resources needed to establish an ISO 13485-compliant QMS to support CE marking of their first advanced NGS diagnostic test under IVDR.<\/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>MDx implemented a staged QMS development approach, prioritizing key processes needed for immediate regulatory requirements while building a scalable framework for future growth.<\/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\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p>ISO 13485 certification achieved within 6 months with zero major nonconformities, enabling the client to proceed with IVDR technical documentation submission on schedule.<\/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\/risk-management-remediation-for-class-iib-medical-device\/\">\n                                                <div class=\"subtitle\">Risk Management Remediation for Class IIb Medical Device<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p>A Class IIb medical device manufacturer received major nonconformities related to risk management during their MDR surveillance audit, threatening their certification status.<\/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\/challenge.svg\" alt=\"Solution\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Solution <\/span>\n                                        <p>MDx conducted a comprehensive risk management file review, facilitated new risk analysis sessions, and implemented a revised ISO 14971:2019-compliant risk management process.<\/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\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p>All nonconformities closed within the required timeframe, with MDx&rsquo;s approach receiving positive feedback from the Notified Body for its thoroughness and compliance.<\/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\/mdsap-preparation-for-global-ivd-manufacturer\/\">\n                                                <div class=\"subtitle\">MDSAP Preparation for Global IVD Manufacturer<\/div>\n                                            <div class=\"list\">\n                                                    <div class=\"list-item\">\n                                                                <div class=\"icon\">\n                                    <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/challenge.svg\" alt=\"Challenge\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Challenge <\/span>\n                                        <p>A global IVD manufacturer needed to achieve MDSAP certification to maintain market access in Canada, Brazil, Australia, and Japan, with a compressed 7-month timeline.<\/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>MDx deployed a team of QMS experts and former auditors to conduct a gap assessment, implement remediation, and conduct comprehensive mock audits across multiple sites.<\/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\/result.svg\" alt=\"Result\" \/>\n                                <\/div>\n                                                                <div class=\"content\">\n                                    <div class=\"wrapper\">\n                                        <span class=\"title\"> Result <\/span>\n                                        <p>Successful MDSAP certification with only minor findings, achieved on schedule and maintaining uninterrupted global market access.<\/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\">Voir les \u00e9tudes de cas<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/section>\n\n<section id=\"block_3394fcf3742ced8d87fff784623fc759\" class=\"testimonials\" style=\"background-image: url(&#039;https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/bbeb7b9bdd90652ff3fc408400879d341b937fae.jpg&#039;);\">\n        <div class=\"testimonials--bg\">\n      <img decoding=\"async\" src=\"https:\/\/mdxcro.com\/wp-content\/uploads\/2025\/08\/bbeb7b9bdd90652ff3fc408400879d341b937fae.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 transformed our quality system from a paperwork burden to a business advantage. Their practical approach to ISO 13485 implementation improved our processes while ensuring we metall regulatory requirements.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Quality Director                                                                 <br>\n                                European Medical Device Manufacturer                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0The mock audit conducted by MDx&rsquo;s former Notified Body auditors was eye-opening. Their insights helped us address critical gaps before our actual certification audit, resulting in zero major findings for our IVD product line\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Regulatory Affairs Manager                                                                 <br>\n                                Global IVD Diagnostics Company                                        \n                            <\/p>\n                                            <\/div>\n                                    <div class=\"slider-item\">\n                                                    <p class=\"quote\">\u00ab\u00a0MDx helped us rework our risk management file and CAPA system to meet ISO 14971 and ISO 13485 expectations. The remediation was practical, fast to implement, and it cut our major audit findings to zero in the next surveillance audit.\u00a0\u00bb<\/p>\n                                                                            <p class=\"author\">\n                                Head of Quality &#038; Compliance                                                                <br>\n                                Mid-Size European MedTech Company                                        \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_15899a07284e5d78ec4819a34da247a5\" class=\"faqs\" style=\"padding-top: Par d\u00e9faut; padding-bottom: Par d\u00e9faut; margin-top: Par d\u00e9faut; margin-bottom: Par d\u00e9faut; \">\n    <div class=\"container\">\n    <div class=\"content\">\n      <div class=\"column\">\n                  <h2 class=\"headline\">Questions fr\u00e9quemment pos\u00e9es<\/h2>\n                          <a class=\"button bouton--par d\u00e9faut\" 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\">En quoi l\u2019approche de MDx pour la mise en \u0153uvre du SMQ diff\u00e8re-t-elle de celle d\u2019autres consultants ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nos experts qualit\u00e9 disposent \u00e0 la fois d\u2019une exp\u00e9rience en organisme notifi\u00e9 et en industrie, ce qui nous permet de mettre en place des syst\u00e8mes \u00e0 la fois conformes et pragmatiques. Nous d\u00e9veloppons des solutions \u00e0 la bonne dimension, en fonction de la taille de votre organisation, de vos ressources et de vos besoins r\u00e9glementaires, plut\u00f4t que d\u2019imposer des mod\u00e8les uniques. Notre double expertise des r\u00e9glementations dispositifs et DIV garantit que votre SMQ couvre les exigences sp\u00e9cifiques \u00e0 vos types de produits.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx peut-il fournir des services temporaires de gestion de la qualit\u00e9 pendant les transitions ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Oui. Nous proposons des solutions de gestion de la qualit\u00e9 int\u00e9rimaires, notamment des responsables qualit\u00e9 \u00e0 temps partiel, du support AQ \u00e0 distance et des \u00e9quipes virtuelles, afin de maintenir la conformit\u00e9 lors de changements organisationnels, de phases de croissance ou de manques de ressources. Ces services peuvent \u00eatre particuli\u00e8rement utiles lors de transitions entre cadres r\u00e9glementaires, comme de l\u2019IVDD \u00e0 l\u2019IVDR ou du MDD au MDR.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment vous assurez-vous que notre SMQ r\u00e9sistera \u00e0 l\u2019examen d\u2019un organisme notifi\u00e9 ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Notre \u00e9quipe comprend d\u2019anciens auditeurs d\u2019organismes notifi\u00e9s de premier plan, qui r\u00e9alisent des \u00e9valuations approfondies de pr\u00e9-certification en appliquant la m\u00eame approche et les m\u00eames standards que les audits officiels. Cette perspective interne nous permet de traiter les probl\u00e8mes potentiels avant votre audit formel. Pour les fabricants de DIV, nous disposons de sp\u00e9cialistes des produits de classe C et D, qui comprennent le niveau de contr\u00f4le renforc\u00e9 auquel ces produits sont soumis.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">MDx accompagne-t-il la certification MDSAP ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Absolument. Nous disposons d\u2019une expertise sp\u00e9cifique des exigences MDSAP et fournissons des \u00e9valuations des \u00e9carts, le d\u00e9veloppement de la documentation et la pr\u00e9paration aux audits pour toutes les r\u00e9gions participantes au MDSAP (\u00c9tats-Unis, Canada, Br\u00e9sil, Australie et Japon). Notre \u00e9quipe a accompagn\u00e9 avec succ\u00e8s plusieurs entreprises dans l\u2019obtention de la certification MDSAP ainsi que lors des audits de surveillance.  <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Comment abordez-vous la gestion des risques selon les types de produits ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nous mettons en \u0153uvre des strat\u00e9gies de gestion des risques adapt\u00e9es \u00e0 votre type de produit et \u00e0 votre technologie. Pour les DIV, nous nous concentrons sur des \u00e9l\u00e9ments tels que le risque de faux r\u00e9sultats, l\u2019impact clinique et la manipulation des \u00e9chantillons. Pour les dispositifs m\u00e9dicaux, nous mettons l\u2019accent sur la s\u00e9curit\u00e9 des patients, les performances du dispositif et les risques li\u00e9s \u00e0 l\u2019utilisation. Pour les logiciels, nous int\u00e9grons l\u2019ISO 14971 avec l\u2019IEC 62304 et les exigences de cybers\u00e9curit\u00e9. Dans tous les cas, nous veillons \u00e0 ce que la documentation r\u00e9ponde aux exigences r\u00e9glementaires applicables.    <\/span><\/p>\n                  <\/div>\n                <\/div>\n              <\/li>\n                          <li class=\"faq-item\">\n                <div class=\"faq-question\">Qu\u2019est-ce qui rend les audits simul\u00e9s de MDx plus efficaces qu\u2019une auto-\u00e9valuation ?<\/div>\n                <div class=\"faq-answer\">\n                  <div class=\"faq-answer-inner wysiwyg\">\n                    <p><span style=\"font-weight: 400\">Nos audits simul\u00e9s sont r\u00e9alis\u00e9s par d\u2019anciens auditeurs d\u2019organismes notifi\u00e9s ayant men\u00e9 des centaines d\u2019audits de certification r\u00e9els. Ils appliquent les m\u00eames techniques, les m\u00eames axes de contr\u00f4le et les m\u00eames crit\u00e8res d\u2019\u00e9valuation que les principaux organismes notifi\u00e9s, offrant une pr\u00e9paration authentique qui identifie des probl\u00e8mes que les auto-\u00e9valuations ne d\u00e9tectent g\u00e9n\u00e9ralement pas. Nous adaptons \u00e9galement les audits simul\u00e9s \u00e0 vos types de produits et \u00e0 vos cadres r\u00e9glementaires (MDR, IVDR, FDA, MDSAP).  <\/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\":\"En quoi l\u2019approche de MDx pour la mise en \u0153uvre du SMQ diff\u00e8re-t-elle de celle d\u2019autres consultants ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nos experts qualit\u00e9 disposent \u00e0 la fois d\u2019une exp\u00e9rience en organisme notifi\u00e9 et en industrie, ce qui nous permet de mettre en place des syst\u00e8mes \u00e0 la fois conformes et pragmatiques. 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Notre \u00e9quipe a accompagn\u00e9 avec succ\u00e8s plusieurs entreprises dans l\u2019obtention de la certification MDSAP ainsi que lors des audits de surveillance.\"}},{\"@type\":\"Question\",\"name\":\"Comment abordez-vous la gestion des risques selon les types de produits ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nous mettons en \u0153uvre des strat\u00e9gies de gestion des risques adapt\u00e9es \u00e0 votre type de produit et \u00e0 votre technologie. Pour les DIV, nous nous concentrons sur des \u00e9l\u00e9ments tels que le risque de faux r\u00e9sultats, l\u2019impact clinique et la manipulation des \u00e9chantillons. Pour les dispositifs m\u00e9dicaux, nous mettons l\u2019accent sur la s\u00e9curit\u00e9 des patients, les performances du dispositif et les risques li\u00e9s \u00e0 l\u2019utilisation. Pour les logiciels, nous int\u00e9grons l\u2019ISO 14971 avec l\u2019IEC 62304 et les exigences de cybers\u00e9curit\u00e9. Dans tous les cas, nous veillons \u00e0 ce que la documentation r\u00e9ponde aux exigences r\u00e9glementaires applicables.\"}},{\"@type\":\"Question\",\"name\":\"Qu\u2019est-ce qui rend les audits simul\u00e9s de MDx plus efficaces qu\u2019une auto-\u00e9valuation ?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Nos audits simul\u00e9s sont r\u00e9alis\u00e9s par d\u2019anciens auditeurs d\u2019organismes notifi\u00e9s ayant men\u00e9 des centaines d\u2019audits de certification r\u00e9els. Ils appliquent les m\u00eames techniques, les m\u00eames axes de contr\u00f4le et les m\u00eames crit\u00e8res d\u2019\u00e9valuation que les principaux organismes notifi\u00e9s, offrant une pr\u00e9paration authentique qui identifie des probl\u00e8mes que les auto-\u00e9valuations ne d\u00e9tectent g\u00e9n\u00e9ralement pas. Nous adaptons \u00e9galement les audits simul\u00e9s \u00e0 vos types de produits et \u00e0 vos cadres r\u00e9glementaires (MDR, IVDR, FDA, MDSAP).\"}}]}  <\/script>\n\n<section id=\"block_1c3f7848fe886688b8e1f331a7cb6c36\" 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\">Une expertise qualit\u00e9 et conformit\u00e9 au service de votre r\u00e9ussite r\u00e9glementaire<\/h2>\n                \n                                    <div class=\"description wysiwyg\">\n                        <p><span style=\"font-weight: 400;\" data-mce-style=\"font-weight: 400;\">Que vous mettiez en \u0153uvre l\u2019ISO 13485, que vous passiez au MDR\/IVDR ou que vous pr\u00e9pariez un audit critique, MDx vous apporte l\u2019expertise en qualit\u00e9 et gestion des risques dont vous avez besoin pour une conformit\u00e9 orient\u00e9e business et une r\u00e9ussite r\u00e9glementaire.<\/span><\/p>\n<p><b>Une qualit\u00e9 qui tient ses promesses. Une conformit\u00e9 qui dure. <\/b><\/p>\n                    <\/div>\n                            <\/div>\n\n                            <div class=\"button-wrapper\">\n                                                                        <a href=\"https:\/\/mdxcro.com\/fr\/contact\/?utm_source=qty_risk_audit\" class=\"button bouton--secondaire\" target=\"\">\n                                R\u00e9server une \u00e9valuation du syst\u00e8me qualit\u00e9                            <\/a>\n                                                                                                <a href=\"#\" class=\"button bouton--secondaire\" target=\"\">\n                                Acc\u00e9der \u00e0 notre guide de mise en \u0153uvre du SMQ                            <\/a>\n                                                            <\/div>\n                    <\/div>\n    <\/div>\n<\/section>\n","protected":false},"featured_media":0,"parent":0,"menu_order":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-11858","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>Services de gestion de la qualit\u00e9 et des risques | Experts ISO 13485 &amp; 14971<\/title>\n<meta name=\"description\" content=\"Services de gestion de la qualit\u00e9, d\u2019\u00e9valuation des risques et d\u2019audit men\u00e9s par des experts pour les dispositifs m\u00e9dicaux et les DIV. 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