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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001: Difference between revisions

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|HasDocument=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
|has_document=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
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|tags_display=[[Glossary:TAG-00208-Dev-ers|Device deficiency]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00215-Cor-ahm|CAPA]], [[Glossary:TAG-00213-Ser-wie|Serious incident]]
 
|comment=Repeated entry: 3.4.2 ++ 5.4.2
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 3 — Unit 3.4.2
|-
! Scope
| MD
|-
! Document part
| 7.4.3
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00208-Dev-ers|Device deficiency]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00215-Cor-ahm|CAPA]], [[Glossary:TAG-00213-Ser-wie|Serious incident]]
|-
! Comment
| Repeated entry: 3.4.2 ++ 5.4.2


Device deficiencies: documentation requirements throughout investigation
Device deficiencies: documentation requirements throughout investigation
|}
|content=7.4.3 Device deficiencies
 
== Content ==
7.4.3 Device deficiencies
[…]
[…]
}}

Revision as of 12:55, 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 3 — Unit 3.4.2
Scope MD
Document part 7.4.3
Language EN
Original entry by Florian Adragna
Contributors
Tags Device deficiency, Documentation, Sponsor, CAPA, Serious incident

Content

7.4.3 Device deficiencies […]

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