FDA QMSR – Introduction to the new regulation in the US
May 23, 2024 1:00 pm - 4:30 pm
FDA QMSR – Introduction to the new regulation in the US
FDA QMSR – Introduction to the new regulation in the US
Half day course – Online
Learn more about the implementation of FDA´s new Quality Management System Regulation (QMSR) and what marketing approval in US requires after February 2, 2026.
Topics
FDA Quality System Regulation, Manufacturer requirements, Device registration requirements and options, Post market requirements.
Target Group
Quality/Regulatory managers, design engineers, quality engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.
Educational goals
Gain 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.
Recommended prior knowledge
Knowledge about ISO 13485:2016. Knowledge of QSR 21 CFR part 820 is beneficial but not required.
Course Leader
Ferenc Dahnér, Senior Quality and Regulatory Consultant.