Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

What does Quality actually mean?

Why do we need a Quality Culture?

The Organisation for Professionals in Regulatory Affairs

3

Insight

“all manufacturers should have a quality management system and a post market surveillance system which should be proportionate to the risk class and type of device in question” Art. 31

“There is no ‘one size fits all’ Quality Management System. The extent at which an organisation controls

their processes is dependent on the nature, size and complexity of an organisation.”

The Organisation for Professionals in Regulatory Affairs

4