Module 16 2022

05/09/2022

 Gathering information on a device to monitor clinical performance  PMS is part of the QMS needed for MDR requirements  Two types of PMS: 1. Reactive: waiting for customer and user input, e.g. complaints systems 2. Proactive: actively looking for information, e.g. post-market clinical studies

The Organisation for Professionals in Regulatory Affairs

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 Risk analysis, controls, and management are “best guesses”  Items need to be modified in light of market experience  Premarket studies may not detect rare events  Long term issues, e.g. durability and biocompatibility  Determine emerging and new risks

The Organisation for Professionals in Regulatory Affairs

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