Jay Crowley

VP of UDI Practice, USDM Life Sciences

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

Session Details

Tuesday, June 19 4:15 PM - 5:00 PM 204 B

s747 - UDI Eats the World: Exploring Regulatory Issues for Life Sciences

How is the UDI (Unique Device Identification) framework being adopted by regulatory agencies around the world? What are the similarities – and differences – in UDI requirements across the FDA, EU and other regulating bodies? And how can medical device manufacturers adopt a programmatic strategy to support both existing and emerging variants? This session will address the UDI issues medical device manufacturers face and what to do about them. It will give participants an opportunity to hear what medical device companies need to be concerned about – including the key considerations in building a programmatic strategy that can support EU-MDR (European Union Medical Device Regulation) standards. Known as the “father of UDI”, Jay Crowley developed the framework and authored key requirements for FDA’s Unique Device Identification System, and led the team responsible for the development and implementation of UDI requirements. This is your opportunity to learn about UDI from the source – and identify key strategies for a sustainable response.

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