The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Clinical Evidence



Document Type:
This document is the first produced by Study Group 5 and is intended to: • introduce the concepts of clinical evaluation and clinical evidence; • examine the relationship between clinical investigation, clinical data, clinical evaluation and clinical evidence; and • serve as guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices (regulatory authorities, conformity assessment bodies, manufacturers of medical devices and their associated industry groups).

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GMP Conferences by Topics

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