Jay Crowley is the Vice President of Medical Device Solutions and Services at USDM Life Sciences.

He developed the framework and authored key requirements for the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) System.

At USDM, Jay provides business process, technology, and compliance solutions for the regulated life sciences industry, and consults with medical device manufacturers to help them achieve regulatory compliance and a competitive advantage with UDI implementation.

Jay held various positions in his nearly 27 years at the FDA, including working with design control regulations to reduce the chance of human errors with medical devices, patient safety, and adverse event reporting. He also worked in the Office of the Commissioner of the FDA, and the Office of Compliance at the FDA. Just prior to USDM, Jay was the Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health.

Jay's recent content

Webinar: UDI Registration in EUDAMED - Why and How to Use It Now
Blog: An Open Letter to Medical Device Regulators
Webinar: Reimagining Medical Device Post-Market Surveillance
Guide: EU MDR Date of Application Readiness
White paper: The Direct Marking of Medical Devices in the U.S. and Europe
Blog: More Medical Device Implications of Brexit

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