Our UDI Platform is an SAP Cloud Platform-based UDI governance solution which integrates operational ERP processes with regulatory governance and submission processes of Unique Device Identification (UDI) related product data on one platform – seamlessly integrated into heterogenous IT landscapes (SAP and non-SAP).
Recommended by SAP for fast UDI Compliance
The UDI Challenge
The European Medical Device Regulation (MDR) becomes effective in May 2021 and draws attention to Unique Device Identification (UDI), but did you know that UDI will become a global challenge?
Solution
The UDI Platform is the strategic answer to your UDI Challenge - it enables you to cover multiple regulatory requirements on UDI with one end-to-end workflow-based UDI data governance and submission solution.
Content Packages
Cover the requirements of different regulatory authorities with our preconfigured Content Packages to achieve global UDI Compliance!
Managed Service
No need to worry about changing requirements! We monitor the market requirements and implement upcoming changes by existing authorities timely into your Cloud solution account for continuous compliance.
SAP Integration
Benefit from a native integration into your hybrid SAP Landscape! We support various technologies to seamlessly integrate our SAP Cloud Platform-based UDI Platform in your SAP ERP or SAP S/4 HANA (On-Premise or Cloud deployment) systems.
Validation
Cloud-based Solutions require an adapted approach for Computer System Validation (CSV). For this reason, we offer you extensive validation support as well as an automated qualification infrastructure for a smooth validation process.
