ISO 14971 Templates

This collection provides ISO 14971 templates for planning, performing, documenting, and maintaining medical-device risk management. It includes starting structures for the risk management plan and report, hazard analysis, risk evaluation, risk-control decisions, benefit-risk analysis, and the review of production and post-production information.

Use the documents as one traceable lifecycle. Define device-specific risk-acceptability criteria before evaluating risks; identify hazards, sequences of events, hazardous situations, and harms; estimate and evaluate risk; implement and verify controls in the required priority order; assess new risks introduced by those controls; and evaluate the overall residual risk. Link controls to design outputs, verification evidence, usability, clinical evaluation, labelling, and post-market activities.

A generic FMEA alone is not an ISO 14971 risk-management file, and copying example severity or probability values can hide the reasoning your device needs. Obtain and use the applicable standard and ISO/TR 24971 guidance, align the templates with market-specific requirements, and define how complaints, vigilance, CAPA, literature, and trend data trigger reassessment. The final records must remain current throughout the device lifecycle.