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.
- 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