Your Gateway to European Markets

Your EU Authorized Representative for medical devices and IVDs under MDR/IVDR. We handle EUDAMED registration, authority liaison, vigilance reporting, and technical documentation availability across all EU member states.

Post-Brexit representation for the Great Britain market. We manage MHRA communications, maintain technical documentation, and ensure ongoing compliance with UK MDR 2002 requirements.

Your Swiss Authorized Representative for medical devices and IVDs. We coordinate with Swissmedic, manage vigilance reporting, and ensure compliance with Swiss MedDO/IvDO regulations.

Your designated Responsible Person under EC 1223/2009. We ensure CPNP notification, maintain Product Information Files (PIF), review labeling and claims, and act as your authority contact for cosmetic products in the EU market.

UK market representation for cosmetic products. We handle UK SCPN notification, PIF maintenance, and OPSS liaison to ensure your cosmetics comply with UK Cosmetics Regulation requirements.

Representation under the General Product Safety Regulation for non-food consumer products. We provide applicability assessments, safety documentation review, and traceability compliance for products sold in the EU.

Complete registration services for EUDAMED, Swissmedic, DMIDS, and national databases. We handle economic operator registration, device submissions, and UDI compliance to ensure your products are properly registered across all target markets.

Efficient FSC application and legalization services for global market expansion. We prepare documentation, submit applications to German authorities (BfArM), and coordinate apostille and embassy legalization for 50+ destination countries.

Expert identification of correct GMDN codes for your medical devices. We analyze product characteristics, verify classifications, and provide documentation support to ensure accurate nomenclature for EUDAMED and UDI compliance.