ISO 14971 Risk Management
End-to-end Risk Management Files (RMF) including plan, report, hazard analysis, and FMEAs that stand up to audits.
What We Do
Risk management is the backbone of medical device safety. We don't just fill out templates; we build a logical, defensible risk management file that aligns with your device's intended use and safety characteristics.
- Risk Management Plan & Report: Comprehensive documentation aligned to ISO 14971:2019 and ISO/TR 24971 guidance.
- Hazard Analysis: Systematic identification of hazards, hazardous situations, and harms.
- FMEAs (Design & Process): Detailed failure mode and effects analysis with clear risk controls and verification evidence.
- Risk-Benefit Analysis: Robust justification for residual risks, critical for FDA and EU MDR compliance.
Deliverables
Audit-Ready Documentation
Clear Traceability Matrix
Reviewer-Friendly Structure
Post-Market Surveillance Plan