Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001: Difference between revisions
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| | | [[Glossary:TAG-00208-Dev-ers|Device deficiency]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00215-Cor-ahm|CAPA]], [[Glossary:TAG-00213-Ser-wie|Serious incident]] | ||
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Revision as of 17:29, 15 July 2026
| 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 3 — Unit 3.4.2 |
| Scope | MD |
| Document part | 7.4.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Device deficiency, Documentation, Sponsor, CAPA, Serious incident |
| Comment | Repeated entry: 3.4.2 ++ 5.4.2
Device deficiencies: documentation requirements throughout investigation |
Content
7.4.3 Device deficiencies […]
