Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Reference:IMDRF IMDRF – Guidelines - -

From GxPlex

Revision as of 15:08, 29 June 2026 by Gxplex admin (talk | contribs) (1 revision imported)
Jump to: navigation, search



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.