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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5: Difference between revisions

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|tags_display=[[Glossary:TAG-00317-Obj-set|Objective]], [[Glossary:TAG-00304-Pri-tSt|Endpoint]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00077-Inc-gsk|Inclusion criteria]]
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{| class="gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| MD
|-
! Document part
| Annex A
A.5
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
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| Objectives and hypotheses of the clinical investigation
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Β 
== Content ==
A.5 Objectives and hypotheses of the clinical investigation
[...]
[...]
The objectives of the clinical investigation shallΒ  […]
The objectives of the clinical investigation shallΒ  […]
}}

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 β€” Good clinical practice

Official source Official link
Restricted access Yes
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 3 β€” Unit 3.2.2
Scope MD
Document part Annex A

A.5

Language EN
Original entry by Florian Adragna
Contributors
Tags Objective, Endpoint, Clinical investigation, Inclusion criteria

Content

A.5 Objectives and hypotheses of the clinical investigation [...] The objectives of the clinical investigation shall […]

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