The FDA is implementing the new Quality Management System Regulation (QMSR), aligning requirements with ISO 13485 while introducing additional FDA-specific expectations for risk-based processes, documentation, and management accountability. Manufacturers will face deeper inspection focus, increased supplier oversight requirements, and a stronger emphasis on risk-based decision-making across every quality system process. Those beginning preparations now will be better positioned for QMSR readiness ahead of the February 2026 compliance deadline.
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