device identification 3dexperience​

Is an ENOVIA application of the Dassault Systèmes platform. It allows you to create and manage unique identifications for medical devices. Indeed, a device identification (DI) is created for each medical device in accordance with the regulations defined by the regulatory authorities as part of the UDI / FDA unique device identification system.

a.png

This application provides the following capabilities:

  • Manage DIs

  • Add additional identifiers, for example: Secondary ID, Package ID, Storage Information, Processing Information.

  • Automatically manage the transmission of UDI numbers to the FDA Gateway.

  • Gather all the information on a DI

  • Link the DIs to a regulatory registration.

b.png