Quality Management System Regulation (QSMR) and Global Harmonization

On February 2, 2024, the FDA published a Final Rule that changed the map for the medical device industry. By amending 21 CFR Part 820, the FDA is moving away from a US-centric system toward the Quality Management System Regulation, called the QMSR. This isn’t just a title change; it is a move toward global harmonization, aligning U.S. requirements with international consensus standards like ISO 13485. In this course learners will review an overview of the shift from the QSR to the QMSR.