Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments (MR…
MDR 2017/745 and IVDR 2017/746 EU laws establish an EU identification system for medical devices based on a Unique Device Identifier (UDI) and oblige medical device manufacturers to disclose the U…
One of the modules of EUDAMED is Vigilance and Market Surveillance. EUDAMED will become mandatory for device Actors, Vigilance, Clinical Investigation/Performance Studies and Market Surveillance M…
The last few years have brought unprecedented challenges, opportunities, and evolution for companies of all sizes. The small and middle market is no exception. In fact, the pandemic served as an a…
In recent years, decentralized and hybrid clinical trials have emerged as promising alternatives to traditional clinical trials. Decentralized clinical trials (DCTs) refer to studies in which part…
