The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits. The 5-page ...

There comes a time in every relationship where you have to pause and ask: Do we really have a future together? That time for reflection is now for medtech companies serving the European market as ...

Any medical device manufacturer seeking to enter the European market will need to use the services of a notified body in its quest to obtain CE marks for its products, which allow those products to ...