"We were looking for a state-of-the-art cloud-based solution that is modularly expandable, technically scalable and which can meet global UDI requirements. It was important to us that the platform would be easy to explain and could be used intuitively by different user groups. The p36 solution was clearly ahead in all of these areas." -Discover RAUMEDIC's success story
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?
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.
Cover the requirements of different regulatory authorities with our preconfigured Content Packages to achieve global UDI compliance!
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.
Benefit from a native integration into your hybrid SAP landscape! We support various technologies to seamlessly integrate our SAP Business Technology Platform-based UDI Platform in your SAP ERP or SAP S/4 HANA (on-premise or cloud deployment) systems.
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.