Reference:IMDRF IMDRF â Guidelines - -: Difference between revisions
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{{:Document:IMDRF IMDRF â Guidelines -}} | {{:Document:IMDRF IMDRF â Guidelines -}} | ||
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{| class=" | |||
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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| MD | | MD | ||
|- | |- | ||
! | ! Document part | ||
| - | | - | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (EN) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (original language) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Tags (FR) | ||
| Â | | Â | ||
|- | |- | ||
! | ! Comment | ||
| IMDRF/GHTF: international medical device regulatory standards | | IMDRF/GHTF: international medical device regulatory standards | ||
|} | |} | ||
== | == 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 â Auditing | GHTF Study Group 4 â Auditing | ||
Revision as of 14:27, 29 June 2026
| Document information | |
|---|---|
| Reference | IMDRF IMDRF â Guidelines - |
| Validity area | IMDRF |
| Scope(s) | MD |
| Document name | IMDRF â 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 â Auditing
https://www.imdrf.org/documents/ghtf-final-documents/ghtf-study-group-4-auditing
No final document (01-Feb-2024), but archived documents available.