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CATEGORY: QUALITY SYSTEMS
Risk Management
The systematic application of management policies, procedures, and practices to analyzing, evaluating, controlling, and monitoring risk throughout the medical device lifecycle. Governed by ISO 14971.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Risk management systematically identifies, evaluates, controls, and monitors hazards throughout the device lifecycle—typically per ISO 14971 integrated with QMS and clinical evaluation.
PROCESS / STEPS
- Establish risk management plan and team.
- Analyze hazards; estimate/evaluate risks.
- Implement and verify risk controls.
- Review residual risk and production/PMS feedback.
EXAMPLES
- A software update that changes clinical decision logic requires risk file revision.
RELATED GUIDES & TOOLS
SOURCES
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