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类别: QUALITY SYSTEMS
风险管理
在整个医疗器械生命周期中系统应用管理政策、程序和实践来分析、评估、控制和监控风险。由ISO 14971规定。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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.
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SOURCES
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