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Device Identifier (UDI)

Rediscovering the compliance process

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What is UDI?

Our Unique Device Identifier solution for Agile Product Lifecycle Management ensures that the data about UDI is correctly handled and submitted timely to the FDA.

Why do you need UDI?

  • Step by step guidance on how to fill accurate UDI information
  • Segment and assign users different information sections
  • Country specific templates to ease the process of compiling data
  • Converts data to SP HL7 format
  • Allows review & sign off

Benefits of UDI System:

  • Easy to create and update FDA Regulations
  • Mass data transfer to Agile PLM
  • Ensure data is compliant
  • Directly submit UDI to FDA

Essential Components:

  • UDI Wizard
  • Rule Engine Admin Client
  • Agile PLM
  • xEngine

UDI Portal in Action:

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