FDA’s New Medical Device QMSR: What You Need to Know

​Speaker: Kim Trautman, M.S., Medical Device, IVD and Combination Product Expert

​FDA’s new Quality Management System Regulation (QMSR) became effective on February 2, 2026, which is the first revision of 21 CFR 820 since 1996. The FDA incorporated ISO 13485:2016 into the regulation by reference and maintained a few specific U.S. country requirements. In addition, the Federal Register contained the concurrent amendment to Combination Product GMP requirements in 21 CFR Part 4. Hear first-hand from the 1996 QS regulation author and ISO 13485 International TC 210 QMS expert on how these changes will affect medical device manufacturers from the requirements to the comments in the Preamble, to FDA medical device inspections, MDSAP, and more…