{"id":4342,"date":"2023-08-02T10:00:59","date_gmt":"2023-08-02T02:00:59","guid":{"rendered":"https:\/\/regask.com\/?p=4342"},"modified":"2024-10-04T03:26:07","modified_gmt":"2024-10-03T19:26:07","slug":"guide-de-la-fda-sur-les-outils-pour-dispositifs-medicaux","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-medical-device-tools-guidance\/","title":{"rendered":"La FDA am\u00e9ricaine publie des directives r\u00e9vis\u00e9es sur la qualification des m\u00e9dic\u2026"},"content":{"rendered":"<div>\n<div>Ce guide final remplace le document Qualification of Medical Devices Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff publi\u00e9 le 10 ao\u00fbt 2017. Il d\u00e9crit un programme volontaire de qualification des outils de d\u00e9veloppement de dispositifs m\u00e9dicaux (MDDT) destin\u00e9s \u00e0 \u00eatre utilis\u00e9s dans l&#039;\u00e9valuation des dispositifs r\u00e9glement\u00e9s par le CDRH.<\/div>\n<div><\/div>\n<div>En plus de la d\u00e9finition des concepts cl\u00e9s et d&#039;un aper\u00e7u du programme de qualification MDDT, le guide fournit des informations sur le cadre de d\u00e9cision de qualification du CDRH et la communication publique de la d\u00e9cision de qualification.<\/div>\n<div><\/div>\n<div><span style=\"color: #555555;\">Besoin d\u2019en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux ? <\/span><a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/fr\/categorie\/dernieres-informations\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1777980130\">\n\n\t<div id=\"col-351891598\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>This final guidance supersedes Qualification of Medical Devices Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff issued on August 10, 2017. It describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH. In addition to definition of&#8230;<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4342","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Updates Medical Device Tools Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues revised guidance on the qualification of medical device development tools. Stay informed with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/guide-de-la-fda-sur-les-outils-pour-dispositifs-medicaux\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Issues Revised Guidance on Qualification of Medical Devices Development Tools\" \/>\n<meta property=\"og:description\" content=\"The US FDA issues revised guidance on the qualification of medical device development tools. 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