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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3: Difference between revisions

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{{#set:
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|has_document=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
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6.3
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|entry_by=Florian Adragna
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|tags=TAG-00010-Non-Stu ++ TAG-00201-Cli-eSt ++ TAG-00244-Def-ini ++ TAG-00155-Med-Med ++ TAG-00209-Pos-sch
|tags_display=[[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=Definition of non-interventional clinical investigation (post-market, device)
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[…]
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{{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}}
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| MD
|-
! Document part
| Annex I
6.3
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|
|-
! Comment
| Definition of non-interventional clinical investigation (post-market, device)
|}
== Content ==
I.6.3 Non-interventional clinical investigation
[…]

Latest revision as of 13:49, 16 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

Content

I.6.3 Non-interventional clinical investigation […]

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