Clinical Evidence Key Definitions and Concept

• Date: October 05, 2008
• Source: www.ghtf.org

The definitions and concepts contained within this document are intended to apply to the establishment and maintenance of conformity with the relevant Essential Principles for medical devices generally. Specific guidance will be developed in other documents in relation to in vitro diagnostic devices. Similarly, guidance about how to generate, compile and present clinical evidence for the purpose of demonstrating compliance with the Essential Principles for safety and performance of a medical device will be addressed in future documents.

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