The FDA Quality Management System Regulation (QMSR) is undergoing a significant update, with the new FDA QMSR final rule published in January 2024 and set to take effect on February 2, 2026. This update marks a major shift from the existing 21 CFR Part 820 QMSR, aiming to better align the US FDA’s medical device quality management system requirements with the international ISO 13485:2016 standard. If you are involved in medical device manufacturing or quality assurance, under
