In-country Representation

MDSS is a leading Authorized Representative for Medical Devices and In Vitro Diagnostics Devices with 30 years of experience in In-Country Representation. Specializing in Regulatory Affairs, we serve as the main contact for the EU Competent Authorities, MHRA, Swissmedic, FDA, and TGA.

Established in 1994, MDSS is a pioneer in European Representation, recognized for precision and integrity.

Our In-Country Representation services, including EU and Swiss Representation, UK Responsible Person, U.S. Agent, and Australian Sponsor, position your company at the forefront of regulatory compliance and market access.

In addition, we provide support for EUDAMED registration, ensuring seamless integration into the European regulatory framework.

MDSS is certified to EN ISO 13485.

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