Introduction Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called “passive” methods of post-market surveillance activities, as basically the manufacturer does

One of the new requirement introduced with the EU MDR 2017/745 is the one related to the preparation of the Periodic Safety update Report (PSUR). This type of report is

The PMCF - Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements related post-market clinical follow-up plan and report have been further

New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with a new framework of requirements which need to be implemented for

The role of post-market surveillance for medical device manufacturers became more and more important. In this post we give an overview to ISO 20416:2020, a new technical standard with the