GHTF Study Group 5 - Clinical Safety/Performance
This page contains final documents produced by the GHTF Study Group 5. For a list of archived documents, see GHTF Archived Documents.
Technical documents
GHTF code: GHTF/SG5/N6:2012 - Date posted: 2 November 2012
GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012
GHTF code: GHTF/SG5/N7:2012 - Date posted: 2 November 2012
GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012
GHTF code: GHTF/SG5/N8:2012 - Date posted: 2 November 2012
GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012
GHTF code: GHTF/SG5/N5:2012 - Date posted: 10 August 2012
Reportable Events During Pre-Market Clinical Investigations
GHTF code: GHTF/SG5/N4:2010 - Date posted: 18 February 2010
GHTF SG5 - Post-Market Clinical Follow-Up Studies - November 2009