Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023
Agency IQ
OCTOBER 27, 2023
The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices.
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