Pharmaceutical Regulatory Affairs and IPR

Medical device vigilance is the monitoring of the safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action.This to ensure that patient’s and healthcare professional’s safety is monitored and action taken as soon as a safety concern with a medical device arises. Manufacturers are obliged to maintain robust medical device vigilance and post marketing surveillance systems in order to attain and maintain their CE certificate. This session will focus on requirements for a robust medical device

vigilance system in EU and how to achieve a strong QMS.