Interface with EU Competent Authorities and Swissmedic, including management of regulatory queries, inspections, and formal communications.
We act as your primary interface with EU Competent Authorities and Swissmedic, ensuring that all regulatory communications are handled in a clear, timely, and compliant manner. Our role is to facilitate efficient interaction with authorities, reducing the administrative burden on your team while ensuring that obligations are properly addressed.
We manage regulatory queries, coordinate responses, and support communication throughout the lifecycle of your devices. Whether responding to information requests, clarifications, or authority-driven actions, we ensure that all exchanges are accurate, consistent, and aligned with your regulatory documentation.
In the context of inspections or formal reviews, we support preparation and communication with authorities, helping you navigate expectations and maintain a structured approach. Our involvement ensures that interactions are handled professionally and in line with regulatory requirements.
By acting as a reliable point of contact, we help streamline communication with authorities and support ongoing compliance across both the EU and Swiss regulatory frameworks.
Our liaison services include:
- Acting as contact point with EU Competent Authorities and Swissmedic
- Management of regulatory queries and information requests
- Preparation and coordination of responses to authorities
- Support during inspections and regulatory reviews
- Handling of formal communications and notifications
- Alignment of communications with technical documentation and registrations
- Ongoing monitoring of authority interactions and follow-up actions
Your Interface with Regulatory Authorities
We manage communications with EUDAMED and Swissmedic, handling regulatory queries, submissions, and authority interactions on your behalf.
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
Provision of Swiss Authorised Representative services under Swiss MedDO, including local representation, regulatory verification, and acting as the official contact point for Swissmedic.
Let’s work together
Discover how we support medical device manufacturers across the EU and Switzerland
Trusted Expertise
We work as an extension of your team, providing consistent communication, accountability, and long-term regulatory oversight throughout your product lifecycle.