USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, hires Jay Crowley as Vice President of the Unique Device Identification (UDI) practice.
As Senior Advisor for Patient Safety in the Food and Drug Administration's Center for Devices and Radiological Health, Crowley developed the framework and authored key requirements for the FDA's Unique Device Identification system. Crowley also lead the team responsible for the development and implementation of UDI requirements.
At USDM Life Sciences, Crowley will focus exclusively on providing business process, technology and compliance solutions for the regulated life science industry.
"There is nobody more qualified to help our medical device clients become UDI compliant than the person who developed the FDA's compliance rules. That's why Jay Crowley is the ideal person to provide our clients with unmatched guidance through the UDI compliance process," said Kevin Brown, Managing Partner at USDM Life Sciences.
"One of the reasons I chose USDM Life Sciences is because of the well-established relationships they have with the most prominent IT vendors in the world. The developed relationships are a big bonus for USDM Life Sciences clients," said Crowley. "I'm looking forward to helping the medical device industry move forward with UDI compliance and help them utilize the benefits of UDI."
Crowley held a variety of positions over his nearly 27 years at the FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Crowley also worked in the Office of the Commissioner of the FDA, and the Office of Compliance at the FDA.
Crowley will officially start his work at USDM Life Sciences on January 6, 2014.