Build the ISO 14971 risk file
Create the core structure for hazards, controls, residual risk, and review.
This is regulatory background. Complya does not provide a hazard register or a risk-control database; maintain the authoritative risk-management file in your controlled source documents.
A useful risk file starts with intended use, users, environments, foreseeable misuse, hazards, hazardous situations, harms, risk estimation, risk controls, verification of controls, residual risk evaluation, and benefit-risk decisions.
Keep the risk file traceable. Each major risk control should connect to design evidence, labelling, IFU content, verification, validation, or PMS monitoring.
Risk management is not a one-time table. It should stay connected to design changes, clinical evaluation, complaints, vigilance, PMS, and post-market learning.
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.
European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices