Katrin Rosen

An ICU nurse by training, Katrin Rosen started her Regulatory Affairs career with clinical trials and then focused on pharmacovigilance and vigilance. She was working with big pharma and in the MedTech industry for more than 10 years where she was in charge for several projects and the DSMB Project Management.

In 2018, Katrin founded her own company offering unique regulatory consulting services. Together with her team, she developed the online database Daedalus® believing that a sparkling idea can change the industry. As of August 2020, Daedalus® provides country-specific requirements for the medical device industry.

Katrin has a vast knowledge and exceptional understanding of country-specific regulatory intelligence not limited to the European Regulations MDR and IVDR. With her insight in many leading markets, she advises medical device companies planning to place their products on foreign markets. Manufacturers are supported in all matters relating to the life cycle of their products, once the devices are marketed abroad. Katrin also offers digital solutions as tailored databases for SMEs.

Blogposts & Case Studies

• Post-Market Surveillance – Der globale Trend zur aktiven Marktüberwachung