About |
Europe IT Consulting GmbH (Basel, Switzerland) is a specialist consultancy for medical-device regulatory IT. We help manufacturers design, govern, and validate UDI master data across the full lifecycle and transmit data securely to authorities—EUDAMED (EU), GUDID & eMDR (FDA), swissdamed (CH), and AusUDID (TGA). Our solutions include SAP-based add-ons and Fiori apps, Excel-to-XML templates, and M2M connectors (AS2/AS4, API), with audit trail, versioning, and packaging hierarchies built in. We deliver end-to-end: process & data-model design, implementation, testing/validation (GAMP5, IQ/OQ/PQ), managed operations, and multilingual training (DE/EN/TR/ES). Clients range from SMEs to global enterprises across DACH and the EU. Our approach: treat UDI compliance as a data lifecycle—from master data to traceability to vigilance.