UDI Compliance & Regulatory Support Services

We help you develop a scalable UDI system strategy that aligns with all your UDI regulation compliance timelines, from FDA, to NMPA, to the EU MDR, and beyond. Our approach supports timely UDI registration, ensures readiness for global UDI compliance dates, and adapts to evolving UDI requirements. 

We support medical device manufacturers in selecting and assigning the correct UDI identifiers using accredited issuing agencies like GS1. Our guidance ensures your UDI are structured correctly from the start, forming a solid foundation for downstream activities such as updating UDI labeling or submitting data into regulatory databases like GUDID and EUDAMED. Whether you're launching a new product or updating existing UDI records, we help you navigate the assignment process with clarity and compliance. 

We help ensure your UDI labels meet global regulatory requirements by guiding you through the interpretation of global UDI labeling requirements, such as those in the FDA UDI regulation and the EU MDR. Our support includes identifying required data elements, providing UDI label examples, and reviewing content for accuracy and consistency—keeping your labeling audit-ready and compliant. 

Choosing the right UDI label software or data management platform is critical. We help you evaluate and implement systems that support UDI format standards, integrate with the GUDID and EUDAMED UDI database, among others, and align with your operational needs.

Our experts manage the collection of complex data elements and submit them to global UDI databases, including the FDA’s GUDID, EU’s EUDAMED, and China’s NMPA database. We ensure your data is complete, validated, and submitted in accordance with each region’s UDI regulation. 

Need extra hands? We provide experienced UDI consultants, UDI contractors, and UDI managers to support your internal teams. Our staffing solutions bring specialized knowledge in UDI procedures, UDI AI tools, and regulatory execution.