Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3
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| Document information | |
|---|---|
| Reference | ISO ISO 14155 -
Clinical investigation of medical devices for human subjects 2020 |
| Validity area | ISO |
| Scope(s) | MD |
| Document name | ISO 14155 -
Clinical investigation of medical devices for human subjects |
| Version / Revision | 2020 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice |
| Official source | Official link |
| Restricted access | Yes |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.2 |
| Scope | MD |
| Document part | Annex I
6.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Non-interventional study, Clinical investigation, Definition, Medical device, PMS & PMCF |
| Comment | Definition of non-interventional clinical investigation (post-market, device) |
Content
I.6.3 Non-interventional clinical investigation […]
