The FDA QMSR final rule January 2024 introduces a modernized framework for medical device quality management system requirements 2026. This update replaces the older 21 CFR Part 820 QMSR, which has been the foundation of US medical device quality regulations for decades. The new regulation emphasizes risk-based approaches, harmonization with global standards, and enhanced post-market surveillance. Why the Transition from QSR to QMSR Matters The transition from QSR to QMSR ref
