ISO 14971:2019
Application of risk management to medical devices
Standard for analysing and managing risk across the device life cycle
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device, Class A IVD, Class B IVD, Class C IVD, Class D IVD
In practice
Mandatory for every device. An iterative process: risk identification, estimation, evaluation, control, then post-market monitoring. The risk management file belongs in the technical documentation.
Official sources
https://www.iso.org/standard/72704.htmlSee where this text lands in your roadmap
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