2020-03-18
This article provides a general overview of what a gap analysis is in the context of the Medical Device Regulation (MDR) 2017/745.
2020-03-17
The article provides a general overview of the medical device regulatory process for manufacturers, as well as additional guidance specifically relevant to standalone software.
2020-03-08
Manufacturers who want to place their medical devices on the European market must refer to the Medical Device Regulation (MDR) 2017/745 to determine the appropriate risk class of their devices.