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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.

GHTF code Document title Date posted Pages
Technical documents
GHTF/SG5/N6:2012 GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb) GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - DOC (68kb 2 November 2012 11
GHTF/SG5/N7:2012 GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb) GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - DOC (466kb) 2 November 2012 20
GHTF/SG5/N8:2012 GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb) GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (190kb) 2 November 2012 21
GHTF/SG5/N5:2012 Reportable Events During Pre-Market Clinical Investigations - PDF (196kb) Reportable Events During Pre-Market Clinical Investigations - DOC (316kb) 10 August 2012 15
GHTF/SG5/N4:2010 GHTF SG5 - Post-Market Clinical Follow-Up Studies - November 2009 - PDF (81kb) GHTF SG5 - Post-Market Clinical Follow-Up Studies - November 2009 - DOC (107kb) 18 February 2010 10
GHTF/SG5/N3:2010 GHTF SG5 - Clinical Investigations - February 2010 - PDF (85kb) GHTF SG5 - Clinical Investigations - February 2010 - DOC (109kb) 12 February 2010 11
SG5-N2R8:2007 GHTF SG5 - Clinical Evaluation - May 2007 - PDF (604kb) 1 May 2007 28
SG5-N1R8 GHTF SG5 - Clinical Evidence - Key Definitions and Concepts - May 2007 - PDF (595kb) 1 May 2007 8
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