The UDI Platform offers the strategic answer to your UDI challenge. It enables you to cover the requirements on Unique Device Identification of regulatory agencies around the world with one end-to-end workflow-based UDI data governance and submission solution – fast, flexible and easy to use.
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:
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).
Due to its intelligent design, our cloud-based solution fits to every company size and existing process configurations.
No matter if you already have most of your device data already on hand or start from the very beginning with your UDI processes – the UDI Platform is configurable to start where you are.
Validation of your data
Simplified release-workflow
Submission management
Data enrichment
Validation of your data
Customized release-workflow
Submission management
Create new maintenance flows
Data enrichment
Validation of your data
Customized release-workflow
Submission management
