The global UDI Challenge

Spotlight on EU MDR

EU MDR and IVDR Transition Period

EU MDR/IVDR Timeline

Besides, keep in mind UDI regulations will remain an ongoing task – you do not only need a Software, but also a reliable Partner who handles all upcoming new Authorities and implements Change Requests timely.

Really try to do it on your own?
7 reasons for a cloud-based and SAP integrated approach

  • Concentrate on your Core Business

    The requirements affecting your UDI Processes are driven by external Regulatory Authorities. A Cloud Service Provider is close to the market and implements upcoming requirements timely.

  • Native SAP Integration

    A SAP Cloud Platform based Solution natively integrates with your existing SAP System Landscape. Leverage your existing Product Master Data in your SAP ERP Systems based on Standard Interfaces and optimize your Data Quality using flexible Approval processes.

  • Less Support effort

    An externally managed Cloud solution delivers required Updates and includes Support, thus relieving the burden from your Support Organization.

  • Simplified Ressource Planning

    A managed Cloud Solution scales for you with every Regulatory Authority. You neither need new hardware nor Software Development Ressources.

  • Clear Test and Change Management

    A managed Solution ensures the majority of tests during Changes of the UDI Process. A clear Change Request Handling and traceability ease to estimate the Regression Test efforts for your Validation.

  • Calculable Costs

    A Cloud Provider offers transparent licensing metrics for the Service Subscription. You achieve Planning security on your whole UDI Lifecycle.

  • Compliance

    A managed Solution covers all requirements on the submission handling to UDI Databases worldwide – stay compliant with a validatable Solution.

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