ISO 14971 Medical Device Risk Management
by Nick Clark | Published April 25, 2026
ISO 14971 establishes the dominant international standard for medical-device risk management. Governed actuation provides the architectural substrate that emerging autonomous-medical-device risk management increasingly requires.
ISO 14971 Frame
ISO 14971 (Medical devices — Application of risk management to medical devices) is the dominant international medical-device risk-management standard, integrated with FDA QSR, EU MDR, and similar regulatory frameworks globally.
Architecture Implications
Risk management requirements increasingly require structural support for autonomous medical devices. Hazard analysis, risk control measure verification, and post-market surveillance all benefit from architectural substrate.
Architectural Mapping
Reversibility classification supports hazard analysis. Stage-gated commitment supports risk-control-measure decomposition. Composite admissibility supports multi-authority medical-device operation.
Standard Evolution
ISO 14971 ongoing revision and emerging integration with FDA PCCP framework push toward structurally-supported architecture.
