Vigilance in action: from mandatory reporting to hazard prevention

The European Medical Device Regulation (MDR) requires medical device manufacturers to ensure vigilance. The MDR stipulates that incidents in connection with medical devices must be recorded and evaluated by the manufacturer and, if necessary, reported to the national competent authorities. This is intended to ensure and improve the health protection and safety of patients, users and third parties.

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 vigilance in practice We will shed light on the reporting obligations and the associated reporting channels and deadlines and show you how to effectively integrate vigilance into your quality management system.

This seminar is aimed at vigilance officers, quality managers, those responsible for regulatory affairs and all specialists involved in the market surveillance of medical devices. Take this opportunity to gain practical knowledge, exchange ideas and clarify your questions.

 

Further information on the event can be found here.

More information