Module 15 2022

19/05/2022

Lecture 2: Clinical Evaluation

Jane Arnold-Round

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Agenda

Clinical Evaluation Process

• Definitions

• Clinical Evaluation Team • The clinical evaluation Plan • Identify the data • Appraise the data • Generate data • Analysis the data • The Clinical Evaluation Report

• Equivalence

• Clinical Evaluation process

• Clinical Evaluation for high risk devices

• Clinical evaluation without clinical data

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

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