MDSS GmbH

With over 30 years of experience, MDSS is a leading Authorized Representative and Regulatory Consulting organization, headquartered in Germany with offices in the USA, the UK, Switzerland, and Australia.

In addition to providing In-Country Representation services — helping streamline global market access through a single, reliable partner — we offer regulatory strategy consulting for medical devices and IVDs, support with pre-submissions and marketing authorization applications to the FDA, and assistance with EU MDR and EU IVDR compliance.

MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech, and the MTAA.