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Your Partner for EU & Swiss Medical Device Compliance
Simplifying EU and Swiss regulatory pathways for medical devices
Regulatory Representation
Acting as your EU Authorised Representative and Swiss Authorised Representative (CH-REP), we ensure full alignment with MDR, IVDR, and Swiss MedDO requirements, including defined legal responsibilities and authority interactions.
Registration & Compliance Management
We manage EUDAMED actor and device registrations, UDI-DI submissions, and Swissmedic notifications, ensuring accuracy, completeness, and ongoing data maintenance in line with regulatory expectations.
UDI & Traceability Management
Oversight of UDI assignment, UDI-DI submission, and traceability systems in accordance with MDR/IVDR, ensuring alignment with EUDAMED requirements.
Regulatory Representation Services for Medical Devices
Trusted by Manufacturers Worldwide
“Working with this team made our EU market entry much smoother than expected. Their guidance on EUDAMED and their role as our Authorised Representative gave us real confidence throughout the process.”
MICHAEL DOE, Regulatory Affairs Manager
Placeholder Medical Technologies Inc.
BOSTON, USA
“Clear communication, strong regulatory knowledge, and a very practical approach. They handled our EUDAMED registrations efficiently and ensured we stayed compliant at every step.”
SOPHIE DOE, Quality & Compliance Director
Placeholder MedTech Solutions Ltd.
TORONTO, CANADA
“A reliable partner for both EU and Swiss requirements. Their representation services and understanding of Swissmedic expectations were invaluable to our expansion strategy.”
JAMES DOE, Head of Regulatory Affairs
Placeholder Medical Devices Ltd.
LONDON, UK
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