Risk Management Files Built to ISO 14971
A complete risk management file, from first hazard analysis to post-production monitoring.
Scope
What’s Included
- Risk management plan
- Hazard identification and analysis
- Risk evaluation
- Risk control measures
- Residual risk evaluation
- Benefit-risk analysis
- Risk management report
- Post-production monitoring plan
Fit
Who It’s For
- Manufacturers building their first risk management file
- Files needing alignment with ISO 14971:2019
- Devices undergoing significant design changes
Deliverables
What You Receive
- Complete risk management file
- Risk management plan and report
- Traceability matrices
- Benefit-risk analysis
Limits
What’s Not Included
- Design changes that implement risk controls — engineering decisions stay with your team
- Verification and validation testing
- Clinical data generation
Timing
Indicative Timelines
Typically 4–8 weeks, depending on device complexity and available verification data.
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Regulatory information last reviewed: 10 August 2026