Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001
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Document Information
| 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
| Scope | MD |
|---|---|
| Document part | 7.4.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Repeated entry: 3.4.2 ++ 5.4.2
Device deficiencies: documentation requirements throughout investigation |
Text
7.4.3 Device deficiencies […]
