UDI Challenges and Opportunities

Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences and architect of the UDI Rule, will help you avoid the challenges some medical device companies had with class III UDI compliance.  He will highlight the issues some companies had and offer solutions that you can apply to your class II and class I UDI programs.

The presentation will include:

  • Challenges/Issues with UDI Program Planning
  • Verification and Validation of Data and Barcodes
  • Comprehensive Program Planning
  • Program Auditing (Is the output of the program compliant?)
  • Live Q & A Session

About the Presenter:

Jay Crowley 6Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. 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.

 

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Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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