Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001: Difference between revisions
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| | | [[Glossary:TAG-00131-Ess-sun|Essential documents]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00152-Tri-gat|Trial master file]], [[Glossary:TAG-00155-Med-Med|Medical device]] | ||
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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 2 — Unit 2.1.1 |
| Scope | MD |
| Document part | Annex E |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Essential documents, Clinical investigation, Trial master file, Medical device |
| 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 [...]
