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Risk Management
ISO 14971 risk management file guidance
Build the ISO 14971 risk file
Create the core structure for hazards, controls, residual risk, and review.
Capture hazards and hazardous situations
Describe what can go wrong and how it can lead to harm.
Link risk controls to evidence and verification
Show that controls exist and that they actually reduce the intended risk.
Evaluate residual risk and benefit-risk
Decide whether remaining risk is acceptable and whether benefits justify it.
Connect risk management to PMS and GSPR
Use risk outputs across surveillance, clinical evaluation, and requirements traceability.