Module 16 2022

07/09/2022

Module 16 Post Market Surveillance and Vigilance for Medical Devices

Introduction to Vigilance Reporting Case Study

John Deavin

Deavin Associates

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Objective: To Review 12 Scenarios

• To assess 12 different scenarios with a view to determining whether the events are reportable ,and, when appropriate, to whom the report should be made

• To debate 1 additional scenario

The Organisation for Professionals in Regulatory Affairs

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