Right-sized programs, from first gap to final submission.
Each service stands alone or assembles with the others. Every engagement starts by understanding what data you have and where it lives.
Attribution Analysis
Review your attribution against current regulatory requirements and map every source field to every target registry.
Teams that need to understand data gaps across their building blocks before committing resources.
We keep you updated as attribution requirements change — no manual schema tracking.
Registry Services
We expedite regulatory submissions or remediate existing records — transform, validate, submit, and resolve rejections.
You need to urgently meet a deadline or correct records already live in a registry.
Remediation follow-up support hours that roll over from month to month.
Last Mile Development
We build, integrate, and automate your data landscape — pipelines, transformations, and validation logic.
Organizations that need custom bolt-on capability connecting source systems to registries.
We know how to build and validate PIMs and construct compliant AI agents.
Solution Acceleration
Solution-agnostic support to help you implement the tools you have chosen — the right way, the first time.
Teams that want a global UDI registry expert embedded on their project.
Ongoing buckets of hours for super-user support whenever you need them.
Where regulatory data quietly breaks.
Inaccurate submissions are far more common than most manufacturers realize. These are the failure modes we find — and fix — most often.
Team turnover
Different regulatory staff over the years bring different interpretations of the same requirement.
Tool migrations
Moving between submission platforms introduces mapping errors and quiet attribute loss.
Cross-registry discovery
Connecting a new registry exposes errors already live in another — the same master data feeds both.
Certificate misalignment
UDI records that don't match the EC certificate or FDA 510(k)/PMA create audit risk.
Hierarchy errors
Misallocated unit-of-use, UDI-DI, UDI-PI, and package records — the most misunderstood area of UDI.
GDSN vs. regulatory divergence
Product data sent to trading partners that conflicts with what's registered in the UDI database.
Common journeys through the blocks.
Most teams start with a gap picture, then hand us the submission or remediation to run end-to-end.
Deep structural gaps convert into building the pipelines that eliminate the root cause permanently.
No submission infrastructure? Begin with managed submissions — attribution analysis is always step one.
Embed a global UDI expert alongside your team on whatever solution you are implementing.