Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002: Difference between revisions
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{{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}} | {{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}} | ||
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| MD | | MD | ||
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| Annex E | | Annex E | ||
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| EN | | EN | ||
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| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
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| Repeated entry: 2.1.1 ++ 2.1.5 | | Repeated entry: 2.1.1 ++ 2.1.5 | ||
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== | == Content == | ||
Essential clinical investigation documents | Essential clinical investigation documents | ||
[...] | [...] | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | MD |
| Document part | Annex E |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Repeated entry: 2.1.1 ++ 2.1.5
Essential clinical investigation documents: all phases (pre-, during- and post-investigation) |
Content
Essential clinical investigation documents [...] Table E.1 - Essential clinical investigation documents prior to clinical investigation [...] Table E.2 - Essential clinical investigation documents during clinical investigation [...] Table E.3 - Essential clinical investigation documents after clinical investigation [...]
