Right-sized programs, from first gap to final submission.
We meet you where we can best provide value. No organization is the same, so we personalize services to specifically meet your needs.
Attribute Analysis
Identify data gaps and harmonize requirements across regulatory databases and recipients, using your existing product data as the starting point.
We're not simply asking “What fields does EUDAMED require?” — rather “What data do you already have, where are the gaps, and how can we create a harmonized and efficient data structure that satisfies additional registries and channels?”
Teams that need to understand data gaps across their building blocks before committing resources to replatform or build integrations.
Submission & Syndication
We take care of the submission and syndication from data sourcing through validation and delivery, including remediation and rejection management. When projects are running late or your team needs additional capacity, we can step in and get the work done quickly.
You need to urgently meet a deadline or correct records already submitted or syndicated to a registry or trading partner.
Integration & Automation
We build, integrate, and automate your data landscape pipelines, transformations, and validation logic. We help design, build and configure a landscape prepared for agentic automation.
Organizations that need development assistance in creating an improved technical landscape.
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 submission and syndication — attribute analysis is always step one.
A new registry or trading partner reopens the question of what your data needs to carry. The loop closes where it started.