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
Labeling Compliance Updates
Data System Selection
Data Collection and Submission
UDI Staff Augmentation
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 the 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.