03.13.14
USDM Life Sciences LLC has recruited a unique device identification expert to help its clients comply with the new government regulation. The Santa Barbara, Calif.-based company has hired Jay Crowley as vice president of its unique device identification (UDI) practice. As senior advisor for patient safety in the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, Crowley developed the framework and authored key requirements for the agency’s UDI system. Crowley also led the team that developed and implemented UDI requirements.
“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,” Kevin Brown, managing partner at USDM Life Sciences, said.
At USDM Life Sciences, Crowley will focus exclusively on providing business process, technology and compliance solutions for the life-science industry.
“One of the reasons I chose USDM Life Sciences is because of the relationships they have with IT vendors. 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 working 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.
USDM Life Sciences is a global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services to clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. USDM Life Sciences provides clients with compliance services during each phase of their drug and product development cycle.
“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,” Kevin Brown, managing partner at USDM Life Sciences, said.
At USDM Life Sciences, Crowley will focus exclusively on providing business process, technology and compliance solutions for the life-science industry.
“One of the reasons I chose USDM Life Sciences is because of the relationships they have with IT vendors. 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 working 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.
USDM Life Sciences is a global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services to clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. USDM Life Sciences provides clients with compliance services during each phase of their drug and product development cycle.