{"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":"fda-leitfaden-fur-medizinprodukte","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-medical-device-tools-guidance\/","title":{"rendered":"US-amerikanische FDA ver\u00f6ffentlicht \u00fcberarbeitete Leitlinien zur Qualifizierung von Medikamenten"},"content":{"rendered":"<div>\n<div>Diese endg\u00fcltige Richtlinie ersetzt die \u201eQualifizierung von Entwicklungstools f\u00fcr Medizinprodukte: Leitfaden f\u00fcr die Industrie, Toolentwickler und Mitarbeiter der Food and Drug Administration\u201c vom 10. August 2017. Sie beschreibt ein freiwilliges Programm zur Qualifizierung von Entwicklungstools f\u00fcr Medizinprodukte (MDDTs) zur Verwendung bei der Bewertung von Ger\u00e4ten, die vom CDRH reguliert werden.<\/div>\n<div><\/div>\n<div>Neben der Definition der Schl\u00fcsselkonzepte und einem \u00dcberblick \u00fcber das MDDT-Qualifizierungsprogramm enth\u00e4lt der Leitfaden Informationen zum CDRH-Qualifizierungsentscheidungsrahmen und zur \u00f6ffentlichen Kommunikation der Qualifikationsentscheidung.<\/div>\n<div><\/div>\n<div><span style=\"color: #555555;\">M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte erfahren? <\/span><a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/div>\n<\/div>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/regask.com\/de\/kategorie\/neuesten-erkenntnisse\/medical-devices-latest-insights\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-441771119\">\n\n\t<div id=\"col-637378173\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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 v27.2 (Yoast SEO v27.3) - 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\/de\/fda-leitfaden-fur-medizinprodukte\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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. Stay informed with RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/fda-leitfaden-fur-medizinprodukte\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-02T02:00:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-03T19:26:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/09\/Therapeutic-goods-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u00a0Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"US FDA Issues Revised Guidance on Qualification of Medi&hellip;\",\"datePublished\":\"2023-08-02T02:00:59+00:00\",\"dateModified\":\"2024-10-03T19:26:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\"},\"wordCount\":173,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Medical Devices\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/\",\"name\":\"FDA Updates Medical Device Tools Guidance | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-medical-device-tools-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/09\\\/Therapeutic-goods-medical-devices.png\",\"datePublished\":\"2023-08-02T02:00:59+00:00\",\"dateModified\":\"2024-10-03T19:26:07+00:00\",\"description\":\"The US FDA issues revised guidance on the qualification of medical device development tools. 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