Bringing new innovations into the healthcare sector is associated with many challenges. One of them is to have the innovation properly tested and documented, taking all legal aspects into account from the start.

Different regulations come into play depending on the type of innovation and whether it is software based, embedded or not, invasive or non-invasive.

The new European medical device regulation came into force May 2021, and the project aims to map and analyze  relevant regulations and apply them to real-life cases in order to generate knowledge to be shared with innovators in academia, healthcare and industry.