Information Management Leaders’ Guide to UDI Compliance

Information Management Leaders’ Guide to UDI Compliance

FAQ: Top 20 Questions and Answers for Complying with the UDI Regulation

Medical device recalls have doubled in the last decade, spurring the US Food and Drug Administration to implement new requirements for the identification and tracking of medical devices on the US market.

For information management leaders who have struggled to get buy-in for a data governance program in the past, the UDI requirement may finally create the necessary urgency to persuade business leaders to provide funding and resources.

This Information Management FAQ was co-created by medical device and data management experts at First San Francisco Partners and Informatica to answer the 20 questions most commonly asked by medical device manufacturers about the UDI regulations.

After reading this FAQ, you should understand:

  1. What the UDI regulations are and who must comply.
  2. The key data challenges involved in meeting UDI requirements.
  3. How to build an effective EIM strategy and deploy a UDI compliance solution quickly and easily.


Thank you for your interest in Informatica.