Welcome to UDI Experts —
Your Partner in Global UDI Compliance
At UDI Experts, we are passionate about delivering comprehensive data solutions tailored to the needs of the medical device industry.
With over a decade of experience, our team is dedicated to helping manufacturers and labelers navigate the complex landscape of Unique Device Identification (UDI) regulations. Whether you're preparing for FDA UDI compliance, aligning with EUDAMED requirements in the EU, or managing global submissions, we are here to support your journey.
Our expertise spans the full spectrum of UDI for medical devices, from initial strategy and system selection to ongoing data governance and maintenance. We assist clients in choosing and implementing the right Product Information Management and Master Data Management systems to ensure seamless integration with their UDI systems. Our services also include UDI label and UDI barcode creation, ensuring your products meet regulatory standards across all markets.
In addition to system implementation support, we offer robust support for UDI data maintenance, including updates due to product changes, mergers, acquisitions, and rebranding. Our consultants are well-versed in the nuances of UDI data submissions, including both FDA GUDID and EUDAMED, providing peace of mind that your data is accurate, timely, and compliant.
Our team brings extensive UDI experience from some of the world’s most prestigious medical device companies, including Baxter and Hospira (a Pfizer company). UDI Experts is currently supporting a leading Fortune 50 tech company with key UDI activities-- including developing procedures, labeling standards, and regulatory strategies. We are also actively involved in a GS1 working group to develop UDI solutions based on European Medical Device Regulation (MDR).
As a forward-thinking regulatory consultancy, UDI Experts is actively investing in AI-driven solutions to further streamline UDI processes. These innovations are designed to reduce manual effort, improve data quality, and accelerate time to market.
We also offer UDI staffing solutions, connecting you with experienced professionals who can support your internal teams during critical phases of UDI implementation or remediation.
Let UDI Experts be your trusted partner in achieving and maintaining global UDI compliance. Contact us today to learn how we can help you simplify complexity and stay ahead of regulatory changes.
Feel confident in your UDI compliance
We’ve got you covered.
UDI Experts is available to address the UDI compliance needs of medical device manufacturers and labelers worldwide.
Contact us for expert assistance in Unique Device Identification, including:
UDI Strategy
UDI Assignment
UDI Labeling Compliance
Data System Selection
UDI Staff Augmentation
Data Collection and Submission
Let Us Navigate UDI — So You Don’t Have To
UDI compliance is complex and far-reaching, impacting every stage of the medical device lifecycle. From assigning compliant UDIs and updating labeling to submitting structured data to global health authorities like the FDA and European Commission—each step demands precision.
In the U.S., manufacturers must manage 65 distinct data elements per product. In the EU, that number nearly doubles—each with its own format and regulatory nuance. And compliance doesn’t end at submission: ongoing product updates must be evaluated for UDI impact and reflected in real time.
That’s where we come in. As your UDI experts, we simplify the process, reduce risk, and help you stay focused on what matters most—delivering safe, effective devices to patients.
At UDI Experts, we are motivated to provide data solutions for your medical device portfolios. With over 10 years' experience, UDI Experts is at the forefront monitoring global regulations, in addition to providing streamlined data solutions to our customers.
Our experts provide support in choosing appropriate ERP/PIM/MDM systems. In addition, we also perform data maintenance (e.g., product changes, company acquisitions, etc.).
UDI Experts is pursuing AI capabilities to streamline the process and bring additional benefits to our clients.