Your Global Center for UDI Solutions
Your partner in Global UDI Compliance
Navigate FDA UDI, EU MDR, and global labeling requirements with structured guidance built for quality, regulatory, and operations leaders.
At UDI Experts, we are passionate about delivering comprehensive UDI 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.
Let UDI Experts be your trusted partner in achieving and maintaining global UDI compliance. Reach out today to learn how we can help you simplify complexity and stay ahead of regulatory changes.
Our Customers
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 up to 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 updates must be 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.
Our Expertise
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 Big Tech Fortune 50 company with key UDI activities, including developing procedures, labeling standards, and regulatory strategies. We are also actively involved in global working groups (e.g., GS1) to develop UDI solutions (e.g., GTIN allocation, Master UDI-DI for Highly Individualized Devices).
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.
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.
UDI Experts also offer UDI staffing solutions, connecting you with experienced professionals who can support your internal teams during critical phases of UDI implementation or remediation.
Key UDI Focus Areas
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 Development
- UDI Assignment
- UDI Labeling Compliance
- UDI Label Printing
- Data System Selection
- Data Collection and Submission
- UDI Staff Augmentation
- UDI Printer IQ/OQ/PQ
- UDI Strategy Development
- UDI Assignment
- UDI Labeling Compliance
- UDI Label Printing
- Data System Selection
- Data Collection and Submission
- UDI Staff Augmentation
- UDI Printer IQ/OQ/PQ
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.
Our work spans UDI strategy, FDA GUDID support, EUDAMED preparation, labeling compliance, and ongoing product data governance for device portfolios operating across global markets.