„Recommended by SAP for fast UDI Compliance“
With our UDI Platform, we provide a Managed Service for the UDI related Product Data Maintenance, Data Validation and Submission Process.
It enables Medical Device Manufacturers to meet the requirements on Unique Device Identification (UDI) of Regulatory Agencies around the world – fast, flexible and easy to use.
The UDI Platform is natively built on SAP Cloud Platform and integrates seamlessly into your existing hybrid SAP Landscape.
„Recommended by SAP for fast UDI Compliance“
The UDI Challenge
The Medical Device Regulation (MDR) in the EU becomes effective in May 2020 and draws attention to Unique Device Identification (UDI). Anyway, UDI is a global Challenge.
SAP Integration
Benefit from a native Process Integration into your hybrid SAP Landscape. We support various technologies to seamlessly integrate our SAP Cloud Platform based UDI Platform with your on Premise or Cloud SAP Systems.
Solution
Our UDI Platform is delivered with preconfigured Content Packages specific for the UDI Databases of different Regulatory Agencies. Use it out-of-the-box as a managed Cloud Solution.
Validation
Cloud based solutions need an adapted approach for Computer System Validation (CSV). Learn, how our Validation Partner Chemgineering supports you in validated and qualified operations of the UDI Platform Solution.
