28 sept 2009 · Depuis sa création en 1992, le GHTF est constitué de représentants des 5 membres fondateurs (issus d'agences nationales de réglementation
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[PDF] GHTF SG1 - International Medical Device Regulators Forum
GHTF/SG1/N055: 2009 FINAL DOCUMENT Global Harmonization Task Force Title: Definitions of the Terms Manufacturer, Authorised Representative,
[PDF] GHTF SG1 Principles of Conformity Assessment for Medical Devices
Principles of Conformity Assessment for Medical Devices SG1 Final Document GHTF/SG1/N40:2006 June 26, 2006 Page 2 of 16 Table of Contents
[PDF] GHTF SG1 Definition of the Terms Medical Device - GS1
16 mai 2012 · Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device' Study Group 1 Final Document GHTF/SG1/N071:2012
[PDF] GHTF SG1 - Definition of the Term Medical Device - 15 March 2011
15 mar 2011 · The primary way in which the Global Harmonization Task Force (GHTF) achieves its goals is through the production of harmonized guidance
[PDF] GHTF SG1 Definition of the Terms Medical Device and In Vitro
GHTF Study Group 1 The document is intended to provide non-binding guidance for use in the regulation of medical devices including In Vitro Diagnostic (IVD)
[PDF] GHTF SG3 Quality management system – Medical devices - FDA
2 nov 2012 · Nonconformity Grading System for Regulatory Purposes and Information Exchange Study Group 3 Final Document GHTF/SG3/N19:2012
[PDF] GHTF SG2(PD) N87R7XML schema for the electronic - Team NB
electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (Based on GHTF SG2
[PDF] Global Harmonization Task Force - ISO
GHTF is not a standards or a standardizing body • No legal status • No formal commitment to implement • Concentrate on regulatory requirements • Develop a
[PDF] GHTF SG1 - Labelling of Medical Devices - June 2005
GHTF/SG1/N43:2005 FINAL DOCUMENT Title: Labelling for Medical Devices Authoring Group: Study Group 1 Endorsed by: The Global Harmonization Task
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