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CATEGORY: STANDARDS
ISO 14971 (Risk Management)
The international standard for the application of risk management to medical devices. ISO 14971 covers risk analysis, risk evaluation, risk control, and residual risk assessment throughout the product lifecycle.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
ISO 14971 is the risk management standard for medical devices across the lifecycle—from design hazards to production and postmarket information.
PROCESS / STEPS
- Identify hazards and hazardous situations.
- Estimate and evaluate risks; implement risk controls.
- Assess residual risk and overall benefit-risk.
- Link production and PMS feedback into the risk file.
EXAMPLES
- A design change triggers risk file update and possibly new verification.
RELATED GUIDES & TOOLS
SOURCES
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