At a glance
- Short name
- ISO 14971
- Jurisdiction
- US
- Also known as / related labels
- ISO 14971:2019 · ISO 13485 · EU MDR Annex I · FDA Risk Management
What this entry covers
Evaluate medical device risk management per ISO 14971:2019, covering risk analysis, risk evaluation, risk control, and post-production risk monitoring throughout device lifecycle
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Official documentation
- Primary official source: https://www.iso.org/standard/72704.html
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