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FDA's New QMSR: A Practical Guide to Harmonization with ISO 13485
This episode unpacks the FDA's new Quality Management System Regulation (QMSR), a landmark change that harmonizes U.S. medical device regulations with the international standard ISO 13485:2016. We cover the specifics of the final rule issued on February 2, 2024, the critical transition timeline ending on February 2, 2026, and the key differences manufacturers must address. Learn about the new requirements for records, labeling, packaging, and how the QMSR will fundamentally change FDA inspections and auditing practices. Key Questions: • What is the FDA's new Quality Management System…
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