GHTF Latest Guidance Documents

SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports
GHTF/SG4/N28R3 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements
SG5/N2R8:2007 Clinical Evaluation
SG5/N1R8:2007 Clinical Evidence – Key Definitions and Concepts
SG1(PD)/N045R12 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
SG1(PD)/N46/R3 Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices

Updated 19 December 2007