An organized risk management file (RMF) under ISO 14971 is the backbone of both MDR and FDA submissions. Use this structure to keep hazards, controls, and evidence aligned.
1) Plan and scope
- Risk management plan with scope, responsibilities, acceptance criteria, and reference standards.
- Device description, intended purpose, user groups, and operating environments.
- Link to applicable regulations/standards (MDR, 21 CFR 820/QMSR, IEC 62304, IEC 60601, IEC 82304).
2) Hazard analysis
- Identify foreseeable hazards (use, software, cybersecurity, supply chain, data quality).
- Include sequences of events and hazardous situations.
- Estimate risk (severity/probability) with clear scoring definitions.
3) Risk controls and traceability
- Control options (inherent safety, protective measures, information for safety).
- Trace each control to verification/validation and to labeling/IFU where relevant.
- Capture residual risk evaluation and benefit-risk justification where controls are limited.
4) Software and cybersecurity
- Software failure modes (FMEA/FTA) tied to architecture and test cases.
- Cybersecurity threats, SBOM, vulnerability handling, and update policy.
- Data integrity and privacy controls (logging, audit, access, encryption).
5) Verification, validation, and usability
- Test matrix linking requirements, hazards, controls, and evidence.
- Human factors/usability validation and mis-use scenarios.
- Environmental/reliability testing where applicable (stress, transport, shelf-life).
6) Post-market surveillance linkage
- PMS plan inputs, trigger thresholds, and trend reporting logic.
- Complaint handling and CAPA linkage back to risk records.
- PMCF/real-world data integration for higher-risk devices.
7) Living file governance
- Version control, change history, and approval records.
- Periodic review cadence and roles.
- Training and competency records for contributors.
How MedReg AI keeps the RMF tight
- Upload your RMF to surface gaps versus ISO 14971 and MDR/FDA expectations.
- Auto-generate a traceability matrix tying hazards, controls, tests, and labels.
- Produce a shareable gap report for design reviews or NB/FDA readiness checks.
Start by aligning your RMF structure, then run a gap analysis to validate completeness. See /solutions for supported regulations or launch a trial from /pricing.
