Transcription of GHTF SG5 Key Definitions and Concepts - IMDRF
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GHTF SG5 Key Definitions and Concepts - IMDRF
SG5(PD)N1R7 PROPOSED DOCUMENT global harmonization Task force Title: clinical Evidence Key Definitions and Concepts Authoring Group: Study Group 5 Date: April 26, 2006 clinical Evidence Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 April 26, 2006 Page 2 of 8 Table of Contents 4 5 5 Definitions and Concepts ..6 clinical investigation ..6 clinical data .. 6 clinical evaluation .. 6 clinical 7 clinical Evidence Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 April 26, 2006 Page 3 of 8 Preface The document herein was produced by the global harmonization Task force , a voluntary group of representatives from medical device regulatory agencies and the regulated industry.
Clinical Evidence – Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 April 26, 2006 Page 3 of 8 Preface The document herein was produced by the Global Harmonization Task Force, a voluntary group
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