The FDA’s new Quality Management System Regulation (QMSR) takes effect February 2, 2026, harmonizing with ISO 13485. This shifts the framework from the old, prescriptive QSR to a more proactive, process-based system rooted in risk-management....
Read MoreIt happens multiple times a year when I interact with pharma, biotech, or medtech clients. We start discussing computerized system use and data integrity, and inevitably, I hear some variation of: “Our electronic data is...
Read MoreAn Unpopular Opinion The recent court decision in American Clinical Laboratory Association (ACLA) v. FDA struck down the FDA’s rule regulating laboratory-developed tests (LDTs), ruling the agency lacked statutory authority. While the court was legally...
Read MoreIn early 2022, the US Food and Drug Administration (FDA) issued its proposed rule for medical devices, the Quality Management System Regulation (QMSR). This proposed rule connects and aligns 21 CFR Part 820 Quality System...
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