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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002: Difference between revisions

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{{#set:
{{ReferenceData
|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
|RefScope=MD
|module=2
|RefDocPart=Annex E
|unit=2.1.5
|RefLanguage=EN
|scope=MD
|RefTags=TAG-00131-Ess-sun ++ TAG-00201-Cli-eSt ++ TAG-00152-Tri-gat ++ TAG-00155-Med-Med
|doc_part=Annex E
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|tags=TAG-00131-Ess-sun ++ TAG-00201-Cli-eSt ++ TAG-00152-Tri-gat ++ TAG-00155-Med-Med
{{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}}
|tags_display=[[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]]
 
|comment=Repeated entry: 2.1.1 ++ 2.1.5
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 2 — Unit 2.1.5
|-
! Scope
| MD
|-
! Document part
| Annex E
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[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]]
|-
! Comment
| Repeated entry: 2.1.1 ++ 2.1.5


Essential clinical investigation documents: all phases (pre-, during- and post-investigation)
Essential clinical investigation documents: all phases (pre-, during- and post-investigation)
|}
|content=Essential clinical investigation documents
 
== Content ==
Essential clinical investigation documents
[...]
[...]
Table E.1 - Essential clinical investigation documents prior to clinical investigation
Table E.1 - Essential clinical investigation documents prior to clinical investigation
Line 51: Line 21:
Table E.3 - Essential clinical investigation documents after clinical investigation
Table E.3 - Essential clinical investigation documents after 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 2 — Unit 2.1.5
Scope MD
Document part Annex E
Language EN
Original entry by Florian Adragna
Contributors
Tags Essential documents, Clinical investigation, Trial master file, Medical device

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 [...]

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