Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001: Difference between revisions
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| | | [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]], [[Glossary:TAG-00078-Exc-ssk|Exclusion criteria]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00086-Fol-Fol|Follow-up visit]] | ||
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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 3.2.2 |
| Scope | MD |
| Document part | Annex A
A.6.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Inclusion criteria, Exclusion criteria, Clinical investigation, Follow-up visit |
| Comment | Repeated entry: 3.2.2 ++ 5.4.1
Protocol content: subject selection criteria and withdrawal |
Content
A.6.3 Subjects a) Inclusion […]
