In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined in Article 88 of the EU Medical Device Regulation (MDR) and Article 83 of the

Field safety notice (FSN) is one of the main tool that can be implemented by a manufacturer to inform customers of any safety-related issue related to their medical devices. It

Field safety corrective action is one of the pillar process associated to post-market surveillance and its key importance is related to the impact of this process to the safety of

The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. Surely, compliant process is directly linked with the safety of the devices on the field

As we know, the European Medical Device Regulations introduced in new requirements for medical device manufacturers, especially in the field of post-market surveillance and of these new requirements is related