PMS compact: Your practical guide to post-market surveillance

The European Medical Device Regulation (MDR) requires medical device manufacturers to conduct post-market surveillance (PMS). The aim of PMS is to identify potential risks or undesirable events that occur during the use of a medical device and to take appropriate measures to protect users.

The corresponding processes in the quality management system (QMS) play a central role in ensuring safety and performance over the entire life cycle of medical devices. PMS is closely linked to both Post-Market Clinical Follow-Up (PMCF) and the manufacturer's risk management process.

Based on her experience working for an internationally active medical device manufacturer, our expert Sophia Zoe Narten will explain to you in this seminar how to implement the legal requirements for PMS in practice. We will shed light on the regulatory principles, the creation of the PMS plan and the resulting PMS reports (PMS Report and PSUR) and show you how to effectively integrate PMS into your quality management system.

This seminar is aimed at quality managers, product managers, vigilance officers and those responsible for regulatory affairs in the medical technology industry. Take this opportunity to gain practical knowledge, exchange ideas and clarify your questions.

 

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