FDA goes 13485 – say hello to QMSR!
Finally! On January 31, 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference, ISO 13485:2016. Medical devices – Quality management systems The final decision was presented four years after […]
