Support with UDI strategy, Basic UDI-DI assignment, and implementation of traceability systems in line with MDR requirements.
We support medical device manufacturers in establishing and maintaining compliant UDI and traceability systems in accordance with MDR requirements. From strategy to implementation, we ensure your products are correctly identified, registered, and traceable throughout their lifecycle.
UDI is a key element of EU regulatory compliance, linking device identification with EUDAMED registration and post-market activities. We work with you to define a practical UDI strategy aligned with your product portfolio and internal processes.
We guide you through Basic UDI-DI assignment, UDI-DI and UDI-PI structuring, and alignment with issuing entities. We also support the integration of UDI requirements into your existing quality and traceability systems, ensuring consistency across labelling, technical documentation, and EUDAMED records.
Our approach is designed to keep UDI implementation clear, efficient, and aligned with regulatory expectations, including ongoing updates and data maintenance.
Our services include:
- Development of UDI strategy aligned with MDR requirements
- Basic UDI-DI assignment and product grouping
- Structuring of UDI-DI and UDI-PI
- Support with issuing entity selection and implementation
- Preparation of UDI data for EUDAMED submission
- Integration of UDI into traceability and quality systems
- Verification of consistency across labelling and documentation
- Ongoing maintenance and updates of UDI data
Ensure Full Traceability Compliance
We support the implementation of UDI systems and ensure alignment with EU traceability requirements, from Basic UDI-DI to EUDAMED integration.
EUDAMED Registrations
Management of Actor registration (SRN), UDI-DI and device registration within EUDAMED, ensuring accurate data submission, module alignment, and ongoing maintenance
Technical Documentation Review
Review and verification of technical documentation in accordance with MDR/IVDR, ensuring completeness, consistency, and readiness for regulatory scrutiny
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.