The newest release of our UDI Platform to version 2.3 is available and adds new features helping medical device companies implementing and living their global UDI strategy.

The following features are new:

  • We enhanced the business process capabilities by offering manual cancellation possibilities including data roll-back for running workflows.

  • The User Interface now shows field descriptions (see screenshot below) based on the standard data element definitions defined by the regulatory authorities. These descriptions can be adapted to give further information to the users. Field descriptions are available from within the governance workflows as well as in the Excel templates for the Mass Upload.

  • It is now possible to create custom data elements as extension of existing data models. The data maintained for these custom attributes is persisted in the UDI area for the device and given authority.

  • The reporting now visualizes data for a device and governance version based on freely configurable page templates. The data can be exported to PDF format, also based on the configurable page templates.

  • For the data derivation from the Common Device Model to an agency specific model, a new templating engine is introduced which allows for complex mappings based on the JSONATA-language. This greatly enhances the data re-use possibilities and thus is a key milestone for the concept of a Common Device Model.

  • For the mass submission of multiple devices, a new application is introduced to select the devices for the submission process.

Screenshot of UDI Platform - Field Explanation
UDI Platform – Field Explanation

Contact us to see a live demo of the UDI Platform 2.3!