Profile
Medical device regulatory guidance from someone who helped shape UDI.
Jay Crowley is USDM's Vice President of Medical Device Solutions and Services and one of the industry's most recognized authorities on Unique Device Identification (UDI). He works with medical device manufacturers that need to turn global regulatory requirements into executable strategies across data, labeling, systems, and operations.
Before joining USDM, Jay spent 26 years at the U.S. Food and Drug Administration, where he held roles connected to design control regulations, patient safety, adverse event reporting, the Office of the Commissioner, the Office of Compliance, and the FDA's Center for Devices and Radiological Health.
Jay helped develop the framework and authored key requirements for FDA's UDI system. That background gives USDM clients practical guidance on how regulators think, where implementation programs often break down, and how to build a defensible approach before deadlines or inspections create urgency.
At USDM, Jay advises medical device companies on global UDI strategy, MDR/IVDR and EUDAMED readiness, GUDID compliance, master data management, database submission planning, and the cross-functional operating model required to keep product data accurate across markets.
