Jay spent 26 years at the FDA, and he developed the requirements for the FDA's UDI system and was one of the authors of the US UDI rule. Jay explains what the delay of enforcement for some class I devices in the US means.

Jay Crowley, VP and UDI Practice Lead at USDM Life Science

What we talked about:

• What are the details of the new UDI and MDR requirements 
• Determining your organization's requirements
• Strategies to implement adapted practices

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