Do you need regulatory assistance to develop a medical device?
Do you need to document the value of the product to investors?
Do you need a clinical investigation?
Our dedicated and experienced team will guide you through the various phases of your product development; from assisting with your quality system and classification, building documentation, as well as conducting clinical investigations and health economic evaluations in Europe or in the United States. We are also experts on the new medical device regulation (MDR) and in vitro medical equipment (IVDR) if you need a gap analysis or assistance to understand the new regulatory framework.
LINK Medical is a North European full-service Contract Research Organization (CRO) with more than 170 employees providing pharmaceutical, biotech, and medical device / in vitro medical device companies.
With offices in Oslo, Copenhagen, Stockholm, Malmö, Uppsala, London and Berlin we have the expertise you need for the entire value chain for your product. We offer a wide range of regulatory services within, clinical studies, health economics/Real World Evidence(RWE), quality assurance, drug safety, data management in clinical investigations, preparation of medical documentation and project management.