Post-market compliance - efficient implementation of PMS, PMCF and vigilance

The European Medical Device Regulation (MDR) obliges medical device manufacturers to perform post-market surveillance (PMS) and post-market clinical follow-up (PMCF). 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.

The aim of the 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. Closely related to this is the topic of vigilance and the associated reporting obligations for manufacturers.

The PMCF, on the other hand, focuses specifically on the clinical evaluation of a medical device after its market launch. The clinical data collected in this context is analysed to determine whether the performance and safety of the medical device is also ensured during use or whether any changes need to be made to the product.

Both PMS and PMCF are closely linked to the manufacturer's risk management process and interact with other QMS processes.

In our seminar, our expert Sophia Zoe Narten will explain the theoretical basics and supplement them with concrete examples from her professional practice. The event format also offers plenty of time for your questions and discussions.

We look forward to your participation!

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