Management of Actor registration (SRN), UDI-DI and device registration within EUDAMED, ensuring accurate data submission, module alignment, and ongoing maintenance.
We provide end-to-end management of EUDAMED registration requirements, supporting manufacturers in meeting their obligations under the MDR and IVDR. From initial setup to ongoing maintenance, we ensure that your data is accurately submitted, consistently structured, and fully aligned with the applicable EUDAMED modules.
Our services cover Actor registration and SRN acquisition, as well as UDI-DI and device registration. We guide you through the requirements of each module, ensuring that all necessary information is complete, correctly formatted, and compliant with regulatory expectations. This reduces the risk of delays, inconsistencies, or rejections during the registration process.
Beyond initial submission, we support the ongoing management of your EUDAMED data. This includes updates, corrections, and alignment with changes to your device portfolio or regulatory status. We work to ensure that your registrations remain accurate and up to date, supporting traceability and transparency requirements across the EU market.
With a structured and practical approach, we simplify the complexity of EUDAMED, allowing you to focus on your core activities while maintaining full regulatory compliance.
Our registry services include:
- Actor registration and Single Registration Number (SRN) acquisition
- UDI-DI and device registration in EUDAMED
- Data preparation and validation in line with module requirements
- Alignment across EUDAMED modules and regulatory documentation
- Submission support and troubleshooting
- Ongoing data maintenance and updates
- Support with regulatory changes impacting EUDAMED obligations
Navigate EUDAMED
with Confidence
From SRN to UDI-DI and device registration, we ensure accurate and compliant submissions across all relevant EUDAMED modules.
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
UDI & Traceability Management
Support with UDI strategy, Basic UDI-DI assignment, and implementation of traceability systems in line with MDR requirements.
Regulatory Liaison
Interface with EU Competent Authorities and Swissmedic, including management of regulatory queries, inspections, and formal communications.
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.