{"id":2830,"date":"2023-01-04T14:27:27","date_gmt":"2023-01-04T14:27:27","guid":{"rendered":"https:\/\/proqc.fr\/blog\/?p=2830"},"modified":"2023-11-02T14:06:08","modified_gmt":"2023-11-02T14:06:08","slug":"programme-audit-unique-des-dispositifs-medicaux-mdsap","status":"publish","type":"post","link":"https:\/\/proqc.fr\/blog\/programme-audit-unique-des-dispositifs-medicaux-mdsap\/","title":{"rendered":"Qu&rsquo;est-ce que le programme d&rsquo;audit unique des dispositifs m\u00e9dicaux (MDSAP) ?"},"content":{"rendered":"<h2>Programme d&rsquo;audit unique des dispositifs m\u00e9dicaux (MDSAP)<\/h2>\n<p class=\"lead text-justify\">Un MDSAP est un type d&rsquo;audit qui se concentre sur l&rsquo;industrie des dispositifs m\u00e9dicaux. Il s&rsquo;agit d&rsquo;un programme \u00e0 caract\u00e8re volontaire qui aide les entreprises \u00e0 am\u00e9liorer leurs syst\u00e8mes de gestion de la qualit\u00e9 et \u00e0 se conformer aux normes internationales. Le programme est bas\u00e9 sur la norme <a href=\"https:\/\/proqc.fr\/solutions\/audits-usines-et-fournisseurs\/audit-iso-13485\/\">ISO 13485<\/a>.<\/p>\n<h2 class=\"mt-5\">Qu&rsquo;est-ce que le MDSAP ?<\/h2>\n<p class=\"text-justify\">Le programme d&rsquo;audit unique des dispositifs m\u00e9dicaux (MDSAP) est un programme international qui harmonise les exigences relatives \u00e0 l&rsquo;audit des syst\u00e8mes de gestion de la qualit\u00e9 (SGQ) des fabricants de dispositifs m\u00e9dicaux. Le programme a \u00e9t\u00e9 \u00e9labor\u00e9 par l&rsquo;International Medical Device Regulators Forum (IMDRF) afin de rationaliser le processus d&rsquo;audit des SMQ pour les entreprises qui fabriquent des dispositifs m\u00e9dicaux vendus dans plusieurs juridictions.<\/p>\n<h2 class=\"mt-5\">Les organismes notifi\u00e9s de l&rsquo;Union europ\u00e9enne<\/h2>\n<p class=\"text-justify\">Le MDSAP a \u00e9t\u00e9 mis en \u0153uvre le 1er janvier 2016, et les premiers audits ont \u00e9t\u00e9 r\u00e9alis\u00e9s en 2017. \u00c0 partir de 2019, les six autorit\u00e9s participantes exigent la certification MDSAP pour les fabricants de dispositifs m\u00e9dicaux qui souhaitent vendre leurs produits dans leurs juridictions respectives.<\/p>\n<h2 class=\"mt-5\">Quelle est la diff\u00e9rence entre ISO 13485 et MDSAP ?<\/h2>\n<p>Il existe quelques diff\u00e9rences essentielles entre la norme ISO 13485 et le MDSAP.<\/p>\n<p class=\"text-justify\">La norme ISO 13485 est une norme de syst\u00e8me de gestion de la qualit\u00e9 sp\u00e9cifique aux fabricants de dispositifs m\u00e9dicaux. Elle est volontaire, mais elle comprend des pratiques exemplaires recommand\u00e9es que les fabricants doivent adopter.<\/p>\n<p class=\"text-justify\">Le MDSAP est un programme d&rsquo;audit qui vise \u00e0 rationaliser la conformit\u00e9 r\u00e9glementaire de diff\u00e9rents pays, comme l&rsquo;Australie, le Br\u00e9sil, le Canada, le Japon et les \u00c9tats-Unis, afin de faciliter la t\u00e2che des fabricants de dispositifs m\u00e9dicaux. L&rsquo;enregistrement au MDSAP est n\u00e9cessaire pour vendre des dispositifs m\u00e9dicaux sur ces march\u00e9s.<\/p>\n<p class=\"text-justify\">La norme ISO 13485 est ax\u00e9e sur la gestion de la qualit\u00e9 au sein d&rsquo;une entreprise, tandis que le MDSAP adopte une approche plus globale de la conformit\u00e9, couvrant les audits, l&rsquo;\u00e9tiquetage des dispositifs et la surveillance post-commercialisation.<\/p>\n<h2 class=\"mt-5\">Dans quel pays le MDSAP est-il obligatoire ?<\/h2>\n<p>Il y a actuellement cinq organismes r\u00e9gionaux de r\u00e9glementation du march\u00e9 qui ont adopt\u00e9 le MDSAP :<\/p>\n<ul>\n<li>Administration des produits th\u00e9rapeutiques d&rsquo;Australie (TGA)<\/li>\n<li>Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA), Br\u00e9sil<\/li>\n<li>Sant\u00e9 Canada (Canada)<\/li>\n<li>Minist\u00e8re japonais de la sant\u00e9, du travail et de la protection sociale (MHLW)<\/li>\n<li>La Food and Drug Administration (FDA) des \u00c9tats-Unis.<\/li>\n<\/ul>\n<p>\u00c0 l&rsquo;heure actuelle, le programme d&rsquo;audit unique des dispositifs m\u00e9dicaux n&rsquo;est obligatoire qu&rsquo;en Australie, au Br\u00e9sil, au Canada et au Japon.<\/p>\n<h2 class=\"mt-5\">Le cycle d&rsquo;audit du MDSAP comprend quatre phases :<\/h2>\n<p>Le cycle d&rsquo;audit du MDSAP comprend quatre phases :<\/p>\n<ol>\n<li><strong>Phase de pr\u00e9-audit :<\/strong> Au cours de cette phase, l&rsquo;auditeur examine la documentation du syst\u00e8me de gestion de la qualit\u00e9 (SGQ) du fabricant afin d&rsquo;\u00e9valuer la conformit\u00e9 aux exigences du MDSAP.<\/li>\n<li><strong>Phase d&rsquo;audit initial :<\/strong> Cette phase comprend une \u00e9valuation sur place du SMQ du fabricant par l&rsquo;auditeur. Au cours de cette phase, l&rsquo;auditeur interrogera le personnel cl\u00e9 et observera les op\u00e9rations afin de d\u00e9terminer la conformit\u00e9 aux exigences du PASMAD.<\/li>\n<li><strong>Phase d&rsquo;audit de surveillance :<\/strong> Au cours de cette phase, l&rsquo;auditeur effectuera des examens p\u00e9riodiques du SMQ du fabricant pour s&rsquo;assurer de la conformit\u00e9 continue aux exigences du PASM. Ces examens peuvent \u00eatre effectu\u00e9s sur place ou \u00e0 distance, selon l&rsquo;accord conclu entre le fabricant et l&rsquo;organisme d&rsquo;audit.<\/li>\n<li><strong>Phase de cl\u00f4ture de l&rsquo;audit :<\/strong> Cette phase finale du cycle d&rsquo;audit comprend un examen de toutes les mesures correctives prises par le fabricant en r\u00e9ponse aux conclusions des phases pr\u00e9c\u00e9dentes de l&rsquo;audit. Une fois que toutes les mesures correctives ont \u00e9t\u00e9 prises de mani\u00e8re satisfaisante, l&rsquo;auditeur d\u00e9livre au fabricant un certificat de conformit\u00e9 indiquant que le cycle d&rsquo;audit du PASM a \u00e9t\u00e9 men\u00e9 \u00e0 bien.<\/li>\n<\/ol>\n<h2 class=\"mt-5\">A propos de Pro QC<\/h2>\n<p>Pro QC est un leader mondial de l&rsquo;assurance qualit\u00e9 qui op\u00e8re depuis plus de 40 ans dans le secteur des dispositifs m\u00e9dicaux. Avec nos solutions, nous couvrons l&rsquo;ensemble du spectre de l&rsquo;assurance qualit\u00e9. Parmi nos services figurent les audits MDSAP, les audits ISO 13485, les audits ISO 9001, les audits ISO 13485, les v\u00e9rifications de fournisseurs, la gestion des fournisseurs, les inspections qualit\u00e9 et bien d&rsquo;autres encore. Contactez-nous \u00e0 l&rsquo;adresse <a href=\"mailto:info@proqc.com\">info@proqc.com<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Programme d&rsquo;audit unique des dispositifs m\u00e9dicaux (MDSAP) Un MDSAP est un type d&rsquo;audit qui se concentre sur l&rsquo;industrie [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":2831,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[247],"tags":[297],"class_list":["post-2830","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-audit","tag-dispositifs-medicaux"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Programme d&#039;audit unique des dispositifs m\u00e9dicaux (MDSAP)<\/title>\n<meta name=\"description\" content=\"Le MDSAP est un programme qui harmonise les exigences en mati\u00e8re de 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