FDA 21 CFR Part 820 Transitioning to QMSR and ISO 13485:2016

Build and maintain a medical device quality management system that meets 21 CFR Part 820 – now the FDA Quality Management System Regulation (QMSR). Learn how ISO 13485:2016 is incorporated by reference, which FDA-specific requirements still apply, and how inspections work under Compliance Program 7382.850. Designed for manufacturers, contract manufacturers, quality, regulatory, and operations teams who must stay inspection-ready.