ISO 14971:2019 — Gap Analysis
Application of Risk Management to Medical DevicesAbout ISO 14971:2019
ISO 14971:2019 specifies the process for medical device manufacturers to identify hazards, estimate and evaluate associated risks, control those risks and monitor the effectiveness of the controls throughout the device lifecycle. It is mandatory under EU MDR 2017/745 and IVDR 2017/746, expected by FDA under 21 CFR 820 and the harmonised standard for medical device risk management worldwide. ISO 14971:2019 supersedes the 2007 version with clarifications on benefit-risk analysis, risk control hierarchy, and post-market activities.
Issuing Body
ISO Technical Committee 210 — Quality management and corresponding general aspects for medical devices
Edition
2019
Coverage
Risk management process for medical devices — risk analysis, evaluation, control, evaluation of overall residual risk, production and post-production information.
Typical Users
Medical device manufacturers and developers; required by EU MDR/IVDR, FDA, Health Canada, TGA, PMDA and other regulators worldwide.
How to use this tool
1. Work through each clause. For each requirement, choose Compliant, Partial, Non-compliant, or leave as Not assessed.
2. Add notes against any requirement to record evidence, gaps, or corrective actions.
3. Click Save progress in the sidebar — data is stored locally in your browser, never uploaded.
4. Export the report as TXT, CSV, JSON or print to PDF for your audit file.
Note: This tool is a guided self-assessment. It does not replace a third-party audit and the authoritative version of the standard must be obtained from the issuing body.
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