Our unique Content Package Concept enables you to use the UDI Platform as a central system for all UDI-related governance and submission processes of multiple regulatory authorities and expand to new markets requiring UDI compliance at any time. The Common Device Model as single-source-of-truth allows you to maintain core attributes of your medical devices once and reuse for submissions to different authorities, keeping your UDI data model consistent and enabling intelligent derivations rather than gathering data for each market.
The UDI Platform integrates seamlessly into your existing heterogenous IT landscapes (SAP and non-SAP) and allows the complete UDI related:
- Data maintenance and enrichment of product master data based on the different data models of regulatory authorities,
- Data validation according to the special requirements of the UDI Databases,
- Data exchange handling with the regulatory authorities,
- Comprehensive reporting of UDI submissions status.
UDI Platform architecture
The UDI Platform is natively built and operated on the SAP Business Technology Platform and integrates your operational ERP processes with regulatory governance and submission processes of UDI related product data on one platform – seamlessly integrated into heterogenous IT landscapes (SAP and non-SAP).