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Are your Class II devices UDI compliant?  

If not, join UDI experts Jay Crowley and Gary Saner for a look at what to expect and what to do in these final weeks before the Class II UDI deadline so you are compliant.

The discussion will include:

  • How to meet the Class II deadline of Sept. 24
  • Strategies for addressing non-compliant product
  • Most important lessons learned for Class II labelers
  • Recommendations for ongoing UDI compliance

Who should attend?

  • UDI Team Leaders/Members
  • Regulatory Leaders/Teams
  • Manufacturing, Operations and Supply Chain Logistics
  • UDI IT Support
  • Distributors with UDI Submission Responsibilities

About the Presenters:

Jay Crowley

Vice President of Unique Device Identification Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.

Gary Saner

Sr. Manager of Information Solutions in the Reed Tech Life Sciences group Gary is a subject matter expert on UDI and other structured content submissions to regulatory agencies. He has over a decade of experience in the Life Sciences industry and has worked for over 30 years in the areas of software development, process management and data conversion.

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