ISO 14971
Medical devices — Application of risk management · 14971 · iso 14971:2019
The risk-management standard for medical devices — mandated by FDA QMSR, MDR, IVDR and ISO 13485. Risk file, hazard analysis, risk control, residual-risk evaluation, risk-management report.
ISO 14971:2019 (with EN 14971:2019+A11:2021 for the EU) defines the risk-management process for medical devices across the lifecycle. Establish context, identify hazards, estimate and evaluate risks, control them, evaluate residual risk, report. The output is the Risk Management File — a living artefact that updates with every change and post-market signal.
V5 stores the risk management file alongside the DHF, links each identified hazard to its risk controls and to the test evidence that proves the controls work.
- ISO 14971:2019
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