ISO 14971 Risk Management Analyzer
Upload your medical device risk management documents and receive an instant gap analysis against ISO 14971:2019.
Sign in with Google to Get StartedWhat this tool does
This application analyses risk management documents for medical devices — including Risk Management Plans, Hazard Analyses, Risk Matrices, and Risk Management Reports — against the requirements of ISO 14971:2019.
Supported document types
- Risk Management Plan (Clause 4.4)
- Hazard Analysis (Clauses 5.1–5.5)
- Risk Matrix (Clauses 5.5 & 6)
- Risk Management Report
What you get
- Section-by-section coverage assessment
- Critical findings and gaps
- Downloadable PDF report
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