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SUMMARY:FDA QMSR – Introduction to the new regulation in the US
DESCRIPTION:Half day course – Online\nLearn more about the implementation of FDA´s new Quality Management System Regulation (QMSR) and what marketing approval in US requires after February 2\, 2026. \nTopics\nFDA Quality System Regulation\, Manufacturer requirements\, Device registration requirements and options\, Post market requirements. \nTarget Group\nQuality/Regulatory managers\, design engineers\, quality engineers\, and others who have direct responsibility for medical device manufacturing\, development and improvement. \nEducational goals\nGain an understanding of QMSR and its relation to ISO 13485:2016 and provide a roadmap outlining the necessary areas to target for successfully entering the US market. \nRecommended prior knowledge\nKnowledge about ISO 13485:2016. Knowledge of QSR 21 CFR part 820 is beneficial but not required. \nCourse Leader\nFerenc Dahnér\, Senior Quality and Regulatory Consultant.  \nSIGN UP»
URL:https://ideon.se/event/fda-qmsr-introduction-to-the-new-regulation-in-the-us/
CATEGORIES:Education
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