Reference:IMDRF IMDRF โ Guidelines - -: Difference between revisions
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| ย | | [[Glossary:TAG-00113-Aud-tQu|Audit]], [[Glossary:TAG-00155-Med-Med|Medical device]], [[Glossary:TAG-00218-Har-pรคi|Harmonised standard]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | IMDRF IMDRF โ Guidelines - |
| Validity area | IMDRF |
| Scope(s) | MD |
| Document name | IMDRF โ 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 | |
|---|---|
| Module | Module 4 โ Unit 4.5.1 |
| Scope | MD |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Audit, Medical device, Harmonised standard |
| Comment | IMDRF/GHTF: international medical device regulatory standards |
Content
IMDRF: International Medical Device Regulators Forum ; Global Harmonization Task Force (GHTF) GHTF Study Group 4 โ Auditing
https://www.imdrf.org/documents/ghtf-final-documents/ghtf-study-group-4-auditing
No final document (01-Feb-2024), but archived documents available.
