Risk Management
ISO 14971 risk management file guidance
5 guides
Build the ISO 14971 risk fileCreate the core structure for hazards, controls, residual risk, and review.Capture hazards and hazardous situationsDescribe what can go wrong and how it can lead to harm.Link risk controls to evidence and verificationShow that controls exist and that they actually reduce the intended risk.Evaluate residual risk and benefit-riskDecide whether remaining risk is acceptable and whether benefits justify it.Connect risk management to PMS and GSPRUse risk outputs across surveillance, clinical evaluation, and requirements traceability.