Transcription of PROPOSED REVISED DOCUMENT - IMDRF
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PROPOSED REVISED DOCUMENT - IMDRF
SG1(PD)/N011R20 PROPOSED REVISED DOCUMENT global harmonization Task force Title: summary technical documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Authoring Group: Study Group 1 of the global harmonization Task force Date: March 5, 2007 summary technical documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Study Group 1 PROPOSED DOCUMENT SG1(PD)/N011R20 March 5, 2007 Page 2 of 26 Table of Contents Rationale, Purpose and Rationale 5 Purpose 5 Scope 5 Intended use of the STED and its preparation.
SG1(PD)/N011R20 PROPOSED REVISED DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices
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