Live Webcast: Solutions for UDI Compliance in Medical Device Companies

The Food and Drug Administration (FDA) released a final ruling that requires most Medical Device companies distributed in the United States carry a unique device identifier, or UDI. All Class 3 devices must be compliant by the summer of 2014 and Class 2 devices within two years of that. Are you ready?

Please join us for a LIVE Webcast on Thursday, December 5th at 2:00pm CDT where Todd Hein – Life Sciences Industry Product Specialist from Oracle and Mike Lieberman – Director, Solution Architecture from Inspirage will highlight industry trends and best practices. This will also include a technical review of the solutions offered by Inspirage, USDM and Oracle.

Featured Topics:

  • The Latest in FDA Rulings
  • Lessons Learned from over 20 UDI Customer Engagements
  • UDI Readiness Survey Results
  • Overview and Demo of the Inspirage and Oracle 3-Step UDI Solution
  • Extract, Standardize and Aggregate Legacy Product Attributes
  • Manage all Device Identifier Attributes within an FDA Auditable Archive under 21 CFR Part 11 Change Control
  • Manage Packaging Hierarchy Dependencies
  • Associate Device Identifiers with Device Master Records
  • Enable HL7 SPL Submittal to the FDA’s GUDID
  • Facilitate Data Flows to the Downstream Supply Chain/Manufacturing System for Consumption onto the UDI Label

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Countdown to UDI: The Inspirage-Oracle Solution

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Julie Legrand

Julie Legrand | Key Contributor

Julie manages PR and marketing for Inspirage. Making her home in San Francisco, Julie has been working in the enterprise software field for nearly 20 years, as both a consultant and marketing professional.