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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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A.5
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== Content ==
A.5 Objectives and hypotheses of the clinical investigation
[...]
[...]
The objectives of the clinical investigation shallΒ  […]
The objectives of the clinical investigation shallΒ  […]
}}

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 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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