Assignment and management of Unique Device Identifiers (UDI) and Basic UDI-DI, required for regulatory traceability of medical devices.
UDI assignment gives each medical device a standardized identifier used for regulatory registration, traceability, and post-market surveillance across major markets including the EU and US.
We help manufacturers assign UDI and Basic UDI-DI correctly and integrate it into labeling and registration submissions.
Medical device manufacturers preparing labeling and registration documentation for regulated markets.
The regulatory step required before you can sell in this market.
Well-prepared submissions face fewer rounds of questions.
Get the classification and documentation right the first time.
We know what this specific regulator actually expects.
We stay engaged as requirements evolve, not just at submission.
A cleared regulatory pathway makes partners more comfortable.
The same straightforward path applies across every standard and service we support.
Gap review & scoping
Build required documentation
Assessment / submission
Certificate / clearance issued
Tell us a bit about your organization and we'll put together a straightforward, competitive quote.