ASQ Temecula Valley Section 0713 & Southern California Local Network Group RAPS announce our next meeting 6:00pm PST Wed 1/21/26
Kim Trautman, M.S., Medical Device, IVD and Combination Product Expert
Talk Description:
FDA's Quality Management System Regulation (QMSR) comes into full effect February 2026! This is FDA's first revision of 21 CFR 820 since 1996. FDA has incorporated ISO 13485:2016 into the regulation by reference and has additional U.S. country specific requirements. In addition, the Federal Register contained the concurrent amendment to Combination Product GMP requirements in 21 CFR Part 4.
See attached pdf for more details! ASQ_0713_invitation_012126_Kim_Trautman_FDA_s_New_Medical_Device_QMSR_What_You_Need_To_Know_-_101425.pdf