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Building Blocks — UDI
UDI Master Data · Regulatory Compliance

Master data isn't one source of truth. It's building blocks.

We help medical-device data, IT, and regulatory teams break master data into governed components — Attribution, Context, Format, Governance — that assemble and reassemble to satisfy EUDAMED, GUDID, AusUDID, Swissdamed, and GDSN. No replatforming required.

Direct connectors maintained for
EUDAMEDGUDIDAusUDIDSwissdamedGDSN
01BLOCK
Attribution
What the data is
02BLOCK
Context
When & where it applies
03BLOCK
Format
How it is expressed
04BLOCK
Governance
Who owns it & how it changes
The scale of UDI, today
2.5M
devices registered in EUDAMED today
~8M
registrations expected industry-wide
8+
UDI registries directly connected
3–5
data systems touch product data
The Challenge

One product. Every registry wants it differently.

UDI systems were built with very different intentions — regulatory, commercial, and patient-safety — so the same device must be reconciled against divergent schemas, formats, and rules across every market you sell in.

Legacy solutions compound the problem
01Custom-built, monolithic enterprise adaptations pile on tech debt.
02RIM/PLM systems built without the context of product master-data specs.
03PIM/MDM systems adapted — but never built — to handle regulatory submissions.
04Standards like GDSN mapped to GUDID, but not to EUDAMED.
udi-systems.diff5 DIVERGENCES
01database schemas
02process flows
03regulatory definitions
04system configurations
05governance protocols
→ result: partial data, silos & tech debt
Our belief

Stop pursuing master data as a single source of truth. Treat it as granular building blocks that assemble & reassemble to the context each registry requires.

Why Building Blocks

A UDI specialist — not a retail platform stretched to fit healthcare.

The big syndication platforms treat medical devices as one commerce vertical among many. We do one thing: get device master data compliant across every UDI registry — and we bring the people to do it, not just the software.

01

Specialist, not generalist

Purpose-built for medical-device UDI, not a retail PXM adapted to healthcare as an afterthought.

02

Services + platform

We run the analysis, submission, and remediation. You get outcomes — not another license to staff and learn.

03

Every registry, direct

Direct connectors to EUDAMED, GUDID, AusUDID, Swissdamed and more — not GDSN syndication alone.

04

Works with your stack

We connect to SAP, Windchill, Akeneo and the systems you already run. No rip-and-replace.

Our solution

Four blocks. Every requirement, accounted for.

We decompose every regulatory and commercial requirement into four building blocks. Model them once, and any submission — to any registry — becomes an assembly step, not a rebuild.

01ATTRIBUTION

What the data is

Property types, schema structures, code lists, and validation rules — the substance of every attribute, mapped to what each registry demands.

02CONTEXT

When & where it applies

Regulatory definitions decide what must be provided, what can change, and whether a value is public, editable, or fixed — per market and per use case.

03FORMAT

How it is expressed

HL7 SPL, EUDAMED XML, JSON, GDSN CIN, or proprietary spreadsheets — the same value, shaped precisely for each recipient's schema.

04GOVERNANCE

Who owns it & how it changes

Occurrence rules, conditional logic, ownership, and cross-functional approval workflows that keep every record defensible under audit.

Worked exampleOne attribute — “Clinical Size” — across three registries
same data · four blocks · three shapes
GUDID
EUDAMED
AusUDID
01Attribution
Size Type · Value · Unit of Measure · Size Type Text
Clinical Size Type · Precision · Max · Min · Value · Measure Unit
Clinical Size Type · Value · Unit of Measure · Type Text
03Format
HL7
XML · UDI-DI
JSON
02Context
Public facing · Editable
Public facing · Non-editable
Public facing · Editable
04Governance
0..1 — applicable if Clinical Size is provided
Required when Precision has a value
Mandatory if device has more than one size
The landscape

Direct connectors to every registry that matters.

We build, maintain, and continuously update direct connectors — so when a schema changes, your blocks stay current automatically.

Regulatory registries
EUDAMEDDUE
European Union
fmtXML
Existing devices: Nov 28, 2026
GUDIDLIVE
United States · FDA
fmtHL7 SPL
Live now
AusUDIDDUE
Australia · TGA
fmtHL7 SPL
First deadline: Jul 2026
SwissdamedDUE
Switzerland
fmtJSON
Registration: Dec 2026
NMPALIVE
China
fmtProprietary
Live now
MFDSLIVE
South Korea
fmtProprietary
Live now
TUDIDLIVE
Taiwan
fmtExcel
Live now
ANVISASOON
Brazil
fmt
Coming shortly
Commercial landscape
GDSN

GDSN Data Pools

Gap analysis and CIN syndication to trading partners — ECHO Data Model, HCDP.

ERP

ERP & Item Master

SAP, Oracle, Microsoft Dynamics — classification, characteristics, batch records.

PIM

Internal Solutions

PIM, PLM and MDM landscapes aggregated into governed building blocks.

AI

Agentic Protocols

Attribution modelled to support AI agents and digital-leaflet delivery.

Start here

Find your attribute gaps before regulators do.

A structured gap assessment maps every required attribute against what your source systems actually hold — across every registry in scope. It is always the first step.

Request a gap assessment →
EUDAMED — existing devices
137days
remaining
Mandatory deadline: Nov 28, 2026. ~2.5M devices registered; ~8M expected. The remediation window is closing.