Module 14: Design Development and Certification of Medical Devices

22/11/2023

PMS plan

Must describe a proactive and systematic process to collect information from:

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

9

What are PMCF studies?

• THIS REQUIREMENT IS NOT WELL UNDERSTOOD • Performing PMS is often not: • Further CLINICAL studies are needed to confirm the performance and safety of the device in real use and.. • To support further design changes…

Masterclass: Lecture 12

The Organisation for Professionals in Regulatory Affairs

10

5