EUDAMED, UDI & Economic Operator Compliance
Regulatory data consistency is an integral part of technical compliance — not merely an administrative registration task. We harmonize technical documentation, UDI assignments, and EUDAMED modules across the commercial supply chain.
The End-to-End Data Consistency Chain
We verify that every device identifier and manufacturer statement remains 100% harmonized across all data touchpoints.
Technical Documentation
Declaration of Conformity
Product Labeling
UDI-DI / Basic UDI-DI
EUDAMED Database
Economic Operator Records
11 Key Registration & Supply Chain Services
Controlled Datasets Eliminate Costly Mismatches
We review regulatory data as one controlled dataset. Minor discrepancies in trade names, Basic UDI-DI grouping, model codes, intended purpose statements, manufacturer address or certificate numbers create severe customs delays and post-market audit nonconformities.
EUDAMED 6 Modules
1. Actor Registration (SRN)
2. UDI & Device Registration
3. Notified Bodies & Certificates
4. Clinical Investigations & Studies
5. Vigilance & Post-Market
6. Market Surveillance
EUDAMED & UDI Setup
Obtain your SRN and structure your Basic UDI-DI hierarchy with our regulatory data experts.
Start EUDAMED SetupUnify Your Device Identification and European Registry Data
Our regulatory informatics specialists structure Basic UDI-DI architectures and manage complete EUDAMED compliance.