Project: Legal Value Chain
How to navigate the world of medical device regulation
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.
This project is part of the MedTech4Health National Development Program for implementation and financed by Sweden’s Innovation Agency and Region Västra Götaland Development Fund.
Sahlgrenska Science Park – project lead
GU Law – overall analysis legal framework and regulations
The Innovation Platform and Gothia Forum in Region Västra Götaland – healthcare input and knowledge
MedTech West – research input
Compliance as a competitive edge
The medtech industry faces a more complex regulatory landscape than ever before. How can compliance be a competitive edge for the medtech industry?Take part of the presentations