Alignment and Impact: What the new FDA Quality Management System Regulation final rule means for GCMI and our medtech design and development customers.
First, the news. “On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities…