Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Module 19: Regulation of In Vitro Diagnostic Medical Devices

Steve Lee, ABHI April 2023

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Day 2: Wednesday 19 th April 2023

13:45 – 14:45

Lecture 7: Post Market Surveillance, Vigilance and FSCA

14:45/15:00 – 15:45 (Includes afternoon break)

Case Study: Apply learnings on PMS, vigilance and FSCA in a group setting using real life examples

Learning Objectives • IVDR post market requirements • Vigilance and FSCA reporting criteria

The Organisation for Professionals in Regulatory Affairs

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