ISO 14155:2020
Clinical investigation of medical devices for human subjects
Good clinical practice for clinical investigations of medical devices
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class IIb medical device, Class III medical device
In practice
Guidance on design, conduct, recording and reporting. Covers the protocol, informed consent, monitoring and adverse event reporting.
Official sources
https://www.iso.org/standard/71690.htmlSee where this text lands in your roadmap
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