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GHTF SG1 - Summary Technical Documentation …

GHTF/SG1/N063:2011. FINAL DOCUMENT. Global Harmonization Task Force Title: Summary Technical Documentation (STED) for demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices Authoring Group: Study Group 1 of the Global Harmonization Task Force Date: March 17th, 2011. Summary Technical Documentation for demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED). Study Group 1 Final Document GHTF/SG1/SG1/N063:2011. Table of Contents Introduction ..5 Rationale, Purpose and Scope ..5 5 Purpose .. 6 Scope .. 6 References ..6 Definitions ..7 Preparation and Use of the Preparation .. 8 The Use of the STED in the Premarket Phase.

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED)

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