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Evaluation ViewAttendees 41

Devices (includes Medical Devices and In Vitro Diagnostics)

Efficient Product Master Data Management: FDA , EUDAMED, and other Medical Device Registry submission/Syndication.

Wednesday, October 4, 2023
4:45 PM – 5:45 PM EDT
Location/Room: 510A
Intermediate Level
Jay Crowley is generally considered the Father of Unique Device Identification. Jeff Holzman has been working in Product Master Data management for over 2 decades, participating in the creation of leading PIM solutions, and the implementation of over 20 production applications supporting UDI, EUDAMED and GDSN.

Come learn what you need to do to be prepared to properly organize your product data for both regulatory and commercial syndication. One size does not fit all in this area. Learn what you can do to streamline your project to be the most effective, cost & time efficient for preparation before engaging potential vendors. Then see options for large complex organizations with many products and complex IT infrastructure, medium and small companies with less complex, less frequently changing product mixes, and less complex IT structure.

Learning Objectives:

  • Understand the resources to be involved and steps to be taken to gather the data needed for EC/EUDAMED and other Medical Device Registry submission requirements. Learn how to most effectively prepare for an effective, time and cost-efficient project, before engaging potential vendors.
  • Understand the roadmap of country/Federal requirements coming for FDA/UDI, EC/EUDAMED type requirements.
  • Know options available to meet global UDI, EUDAMED type requirements.