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Reference:IMDRF IMDRF – Guidelines - -: Difference between revisions

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== Document Information ==
{{:Document:IMDRF IMDRF – Guidelines -}}
{{:Document:IMDRF IMDRF – Guidelines -}}


== Reference Details ==
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! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| MD
| MD
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| -
| -
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
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|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
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|  
|-
|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
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|  
|-
|-
! scope="row" | Comment
! Comment
| IMDRF/GHTF: international medical device regulatory standards
| IMDRF/GHTF: international medical device regulatory standards
|}
|}


== Text ==
== Content ==
IMDRF: International Medical Device Regulators Forum ; Global Harmonization Task Force (GHTF)
IMDRF: International Medical Device Regulators Forum ; Global Harmonization Task Force (GHTF)
GHTF Study Group 4 – Auditing
GHTF Study Group 4 – Auditing

Revision as of 14:27, 29 June 2026



Document information
Reference IMDRF IMDRF – Guidelines -
Validity area IMDRF
Scope(s) MD
Document name IMDRF – Guidelines
Version / Revision -
Status N.A.
Document type Corpus of texts
Language(s) EN
Description IMDRF: International Medical Device Regulators Forum

IMDRF documents - https://www.imdrf.org/documents/library - Technical documents

Global Harmonization Task Force (GHTF) - https://www.imdrf.org/documents/ghtf-final-documents GHTF Study Group 1 - Pre-market Evaluation GHTF Study Group 2 - Post-market Surveillance/Vigilance GHTF Study Group 3 - Quality Systems GHTF Study Group 4 - Auditing GHTF Study Group 5 - Clinical Safety/Performance

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Scope MD
Document part -
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment IMDRF/GHTF: international medical device regulatory standards

Content

IMDRF: International Medical Device Regulators Forum ; Global Harmonization Task Force (GHTF) GHTF Study Group 4 – Auditing

https://www.imdrf.org/documents/ghtf-final-documents/ghtf-study-group-4-auditing

No final document (01-Feb-2024), but archived documents available.