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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6

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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 3.1.4
Scope MD
Document part 5.8.4 - 5.8.6
Language EN
Original entry by Florian Adragna
Contributors
Tags Patient information sheet, Signature, Informed consent, Medical care

Content

5.8.4 Information to be provided to the subject [...] 5.8.5 Informed consent signature [...] 5.8.6 New information […]