Module 15 2022

19/05/2022

The Clinical Evaluation Process

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

13

Clinical Evaluation In the QMS

Clinical Evaluation is a required element of the quality system Article 10.9 (f): “The quality management system shall address at least the following aspects……. ..clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF”

Clinical evaluation procedure: ● Define responsibilities ● Define the output: CEP, CER

● When to start the process, updates ● Interaction with other processes: risk management, design control, instructions for use, technical file, PMS, PMCF….

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

14

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