Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 5: | Line 5: | ||
6.3 | 6.3 | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00010-Non-Stu ++ TAG-00201-Cli-eSt ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med ++ TAG-00209-Pos-sch | ||
| | |RefModule=1 | ||
| | |RefUnit=1.2.2 | ||
}} | }} | ||
| Line 15: | Line 15: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 1 — Unit 1.2.2 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 32: | Line 35: | ||
| | | | ||
|- | |- | ||
! Tags | ! Tags | ||
| | | [[Glossary:TAG-00010-Non-Stu|Non-interventional study]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00155-Med-Med|Medical device]], [[Glossary:TAG-00209-Pos-sch|PMS & PMCF]] | ||
|- | |||
| | |||
|- | |||
| | |||
|- | |- | ||
! Comment | ! Comment | ||
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 1 — Unit 1.2.2 |
| Scope | MD |
| Document part | Annex I
6.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Non-interventional study, Clinical investigation, Definition, Medical device, PMS & PMCF |
| Comment | Definition of non-interventional clinical investigation (post-market, device) |
Content
I.6.3 Non-interventional clinical investigation […]
