Discuss Your Regulatory Needs
We work closely with manufacturers to define clear and effective regulatory strategies. Share your requirements with us, and we will reach out to arrange a meeting and prepare a tailored approach for your EU and Swiss compliance.
Regulatory Liaison
Interface with EU Competent Authorities and Swissmedic, including management of regulatory queries, inspections, and formal communications.
Authorised Representative (EU)
Acting as EU Authorised Representative, including mandate establishment, verification of technical documentation and Declaration of Conformity, and liaison with EU Competent Authorities
EUDAMED Registrations
Management of Actor registration (SRN), UDI-DI and device registration within EUDAMED, ensuring accurate data submission, module alignment, and ongoing maintenance
Swiss Authorised Representation
(CH-REP)
Provision of Swiss Authorised Representative services under Swiss MedDO, including local representation, regulatory verification, and acting as the official contact point for Swissmedic
Swissmedic Registrations
Preparation and submission of device notifications and economic operator registrations with Swissmedic, ensuring compliance with national regulatory requirements for market access in Switzerland
Technical Documentation Review
Review and verification of technical documentation in accordance with MDR/IVDR, ensuring completeness, consistency, and readiness for regulatory scrutiny
Trusted Expertise
We work as an extension of your team, providing consistent communication, accountability, and long-term regulatory oversight throughout your product lifecycle.