GHTF Proposed Document: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
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Canada: Guidance for Manufacturers Preparing A Pre-Market Application Using STED; Draft Guidance for Industry
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Premarket Harmonization: Developing A Common Premarket Submission Dossier
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Notice of Election and Agenda
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Program of the 1st AHWP Technical Committee Meeting and Workshop
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