{"id":59849,"date":"2026-06-22T08:19:27","date_gmt":"2026-06-22T06:19:27","guid":{"rendered":"https:\/\/gxp-training.com\/online-course\/investigation-clinique-des-dispositifs-medicaux-iso-141552020\/"},"modified":"2026-06-22T09:12:01","modified_gmt":"2026-06-22T07:12:01","slug":"investigation-clinique-des-dispositifs-medicaux-iso-141552020","status":"publish","type":"product","link":"https:\/\/gxp-training.com\/fr\/online-course\/investigation-clinique-des-dispositifs-medicaux-iso-141552020\/","title":{"rendered":"Investigation clinique des dispositifs m\u00e9dicaux &#8211; ISO 14155:2020"},"content":{"rendered":"<p>Lorsqu\u2019un dispositif m\u00e9dical \u00e9choue, la cause racine est souvent une faiblesse des preuves cliniques, et non la technologie elle-m\u00eame. Les scandales de l\u2019implant PIP et de la proth\u00e8se de hanche DePuy ASR l\u2019ont prouv\u00e9, et ils ont remodel\u00e9 la mani\u00e8re dont les autorit\u00e9s exigent ces preuves dans le monde entier. L\u2019ISO 14155:2020 est la norme internationale qui r\u00e9git la fa\u00e7on dont les investigations cliniques de <a href=\"\/product-category\/medical-devices-regulatory-training\/\">dispositifs m\u00e9dicaux<\/a> chez des sujets humains sont planifi\u00e9es, conduites et rapport\u00e9es, et elle sous-tend la conformit\u00e9 au RDM (UE) 2017\/745 et \u00e0 la FDA 21 CFR Part 812. Cette formation en ligne de deux heures transforme chaque clause en une m\u00e9thode claire \u00e0 appliquer, du premier sujet au suivi post-commercialisation.   <\/p>\n<p>En dix le\u00e7ons, ce cours certifi\u00e9 couvre chaque section de la norme avec des \u00e9tudes de cas r\u00e9elles, de l\u2019\u00e9thique et la planification jusqu\u2019au reporting de s\u00e9curit\u00e9 et \u00e0 la pr\u00e9paration aux inspections. Son certificat tra\u00e7able vous fournit une preuve pr\u00eate pour l\u2019audit que vous, ou votre \u00e9quipe, \u00eates pr\u00eat \u00e0 appliquer l\u2019ISO 14155 en pratique. <\/p>\n<p>&nbsp;<\/p>\n<p><strong>Ce que vous apprendrez<\/strong><\/p>\n<ul>\n<li>Positionner l\u2019ISO 14155:2020 par rapport au RDM (UE), \u00e0 la FDA 21 CFR Part 812, \u00e0 l\u2019ISO 14971 et \u00e0 l\u2019<a href=\"https:\/\/gxp-training.com\/fr\/online-course\/management-de-la-qualite-pour-les-dispositifs-medicaux-iso-134852016\/\">ISO 13485<\/a><\/li>\n<li>Appliquer les 13 principes de l\u2019ISO-GCP pour planifier une investigation conforme, du CIP et de la Brochure de l\u2019investigateur jusqu\u2019aux statistiques<\/li>\n<li>Piloter un syst\u00e8me de management de la qualit\u00e9 clinique et un monitoring fond\u00e9 sur les risques aux niveaux de l\u2019\u00e9tude, du site et des processus<\/li>\n<li>Classer et d\u00e9clarer les <a href=\"https:\/\/gxp-training.com\/fr\/online-course\/notification-devenements-indesirables-graves-et-traitement-des-cas\/\">\u00e9v\u00e9nements ind\u00e9sirables<\/a>, les effets li\u00e9s au dispositif et les d\u00e9ficiences dans les d\u00e9lais requis<\/li>\n<li>Maintenir la conformit\u00e9 GCP lors de l\u2019utilisation d\u2019outils num\u00e9riques, y compris le consentement \u00e9clair\u00e9 \u00e9lectronique et les \u00e9tudes d\u00e9centralis\u00e9es<\/li>\n<li>R\u00e9ussir une inspection RDM (UE) ou FDA, en s\u2019appuyant sur de v\u00e9ritables constats FDA pour anticiper les \u00e9carts signal\u00e9s par les auditeurs<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>\u00c0 qui s\u2019adresse cette formation<\/strong><\/p>\n<ul>\n<li>Attach\u00e9s de recherche clinique, moniteurs et chefs de projet dans le domaine des dispositifs m\u00e9dicaux<\/li>\n<li>Promoteurs, investigateurs principaux, coordinateurs d\u2019\u00e9tude et infirmiers\/\u00e8res de recherche<\/li>\n<li>\u00c9quipes assurance qualit\u00e9, affaires r\u00e9glementaires et op\u00e9rations cliniques<\/li>\n<li>Professionnels des organismes notifi\u00e9s, des CRO et de la surveillance post-commercialisation<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u00c0 l\u2019issue de la formation, chaque apprenant re\u00e7oit un<strong> certificat valid\u00e9 accr\u00e9dit\u00e9 avec des cr\u00e9dits CPD\/CEU<\/strong>, adapt\u00e9 aux audits et \u00e0 la documentation de conformit\u00e9.<\/p>\n<p>&nbsp;<\/p>\n<h3>Programme<\/h3>\n<p><strong>Le\u00e7on : Bref historique de l\u2019investigation clinique des dispositifs m\u00e9dicaux<\/strong><\/p>\n<p><strong>Le\u00e7on 1 : Champ d\u2019application, structure et paysage r\u00e9glementaire de l\u2019ISO 14155:2020<\/strong><\/p>\n<p><strong>Le\u00e7on 2 : Consid\u00e9rations \u00e9thiques et consentement \u00e9clair\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 3 : Planification de l\u2019investigation clinique<\/strong><\/p>\n<p><strong>Le\u00e7on 4 : Responsabilit\u00e9s du promoteur et syst\u00e8me de management de la qualit\u00e9 clinique<\/strong><\/p>\n<p><strong>Le\u00e7on 5 : Responsabilit\u00e9s de l\u2019investigateur principal<\/strong><\/p>\n<p><strong>Le\u00e7on 6 : Conduite de l\u2019investigation clinique<\/strong><\/p>\n<p><strong>Le\u00e7on 7 : \u00c9v\u00e9nements ind\u00e9sirables, d\u00e9ficiences du dispositif et reporting de s\u00e9curit\u00e9<\/strong><\/p>\n<p><strong>Le\u00e7on 8 : Suspension, arr\u00eat et cl\u00f4ture<\/strong><\/p>\n<p><strong>Le\u00e7on 9 : Suivi clinique post-commercialisation<\/strong><\/p>\n<p><strong>Le\u00e7on 10 : Documents essentiels, audits et pr\u00e9paration aux inspections<\/strong><\/p>\n<p><strong>Conclusion<\/strong><\/p>\n<p><strong>Glossaire<\/strong><\/p>\n<p><strong>\u00c9valuation finale<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lorsqu\u2019un dispositif m\u00e9dical \u00e9choue, la cause racine est souvent une faiblesse des preuves cliniques, et non la technologie elle-m\u00eame. Les scandales de l\u2019implant PIP et de la proth\u00e8se de hanche DePuy ASR l\u2019ont prouv\u00e9, et ils ont remodel\u00e9 la mani\u00e8re dont les autorit\u00e9s exigent ces preuves dans le monde entier. L\u2019ISO 14155:2020 est la norme [&hellip;]<\/p>\n","protected":false},"featured_media":59786,"template":"","meta":{"_acf_changed":false,"content-type":""},"product_brand":[],"product_cat":[255,274,256],"product_tag":[],"class_list":{"0":"post-59849","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-affaires-reglementaires","7":"product_cat-bpc-essais-cliniques","8":"product_cat-dispositifs-medicaux","10":"first","11":"instock","12":"virtual","13":"taxable","14":"purchasable","15":"product-type-subscription"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":null,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Investigations cliniques des dispositifs m\u00e9dicaux selon l\u2019ISO 14155 - Formation certifi\u00e9e pour professionnels<\/title>\n<meta name=\"description\" content=\"Formation certifi\u00e9e ISO 14155 sur les investigations cliniques des dispositifs m\u00e9dicaux, align\u00e9e sur le RDM (UE) et la FDA 21 CFR Part 812. 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