UDI Compliance & Regulatory Support Services

Our UDI Consulting Services

At UDI Experts, we specialize in helping medical device manufacturers navigate the complex world of Unique Device Identification (UDI). Our consulting services are designed to support full compliance with global UDI regulations, including FDA UDI compliance, EU MDR regulation, and NMPA UDI requirements.

Whether you're preparing for UDI implementation, updating existing UDI medical devices, or registering devices in the EUDAMED database, our team delivers strategic, technical, and operational support tailored to your needs.

End-to-end UDI consulting built for medical device manufacturers that need practical, execution-ready support across global regulations.

Why Choose UDI Experts?

Deep expertise in UDI implementation across global markets.

Proven success with UDI registration and database submissions.

Flexible support models, from strategic planning to hands-on execution.

Ongoing support to track and prepare for key global UDI compliance milestones with the latest regulatory information.

Service Areas

UDI Strategy Development

We help you develop a scalable UDI system strategy that aligns with global 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.

UDI Label Compliance

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

UDI Assignment

We support medical device manufacturers in selecting and assigning the correct UDI identifiers using accredited issuing agencies like GS1. Our guidance ensures UDI structures are correct from the start, creating a strong foundation for downstream activities such as UDI labeling updates and submissions to GUDID and EUDAMED.

UDI for Highly Individualized Devices

Our team specializes in UDI compliance for highly individualized devices, including contact lenses, spectacle lenses, spectacle frames, and ready-to-wear reading spectacles. We support end-to-end Master UDI-DI implementation, from defining grouping logic to managing data elements and ongoing compliance.

UDI Software & Data System Selection

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 GUDID and EUDAMED, and align with your operational needs.

UDI Data Collection & Submission

Our experts manage complex data element collection and submissions to global UDI databases, including FDA GUDID, EU EUDAMED, and China NMPA. We ensure data is complete, validated, and submitted in accordance with each region's UDI regulation.

UDI Staff Augmentation

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.

Who we support

We work with medical device manufacturers, labelers, and internal regulatory, quality, labeling, and data teams that need execution-ready UDI support across multiple markets.

Common project types

Clients engage us for remediation programs, new market expansion, FDA GUDID and EUDAMED preparation, label updates, system selection, and data cleanup ahead of submissions.

How we engage

Support can be strategic, hands-on, or embedded through staff augmentation, depending on whether your team needs planning, delivery, or operational bandwidth.

Ready to Simplify Your UDI Journey?

Contact UDI Experts today to schedule a consultation. Let us help you achieve full compliance while keeping your focus on innovation and patient safety.