Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Clinical Evidence and Evaluations

Presented by: Giovanni Di Rienzo, Qserve Group UK

The Organisation for Professionals in Regulatory Affairs

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Contents

A few terms and definitions

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 When do we need Clinical Evidence?  Defining State of the Art  Equivalence  Types of Evidence & Considerations  MDR documentation requirements  Maintaining and updating the clinical evaluation

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The Organisation for Professionals in Regulatory Affairs

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