The ISO 14971 Risk Management Analyzer is a tool by Just Yukti that helps medical device manufacturers perform gap analysis of their risk management documents against ISO 14971:2019.
What this tool does
Upload your risk management PDFs and receive an instant structured assessment of compliance gaps, critical findings, and section-by-section coverage.
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
Your data
We request access to your Google account name and email address only, solely to identify you within the app. Your uploaded documents are never stored. See our Privacy Policy for full details.
