SANTA BARBARA, CA--(Marketwired - May 13, 2014) - USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is pleased to announce Jay Crowley, Vice President of the Unique Device Identification Practice, is the keynote speaker at the European Diagnostic Manufacturers Association (EDMA) and Eucomed workshop called Implementation of a UDI System: A Focus on US FDA Rules. The event is from 9:30am - 4:30pm on Thursday, May 15th in Brussels, Belgium.
Implementation of a UDI System: A Focus on US FDA Rules is a workshop about what medical device manufacturers need to do to comply with the upcoming FDA UDI Final Rule and guidance for the Global UDI Database (GUDID). Crowley will discuss the latest information about the UDI implementation requirements.
"I look forward to continuing to work with the international medical device community on avoiding compliance challenges during the UDI implementation process," said Crowley. "I want to do everything I can to make sure their UDI adoption process is straightforward and successful."
As Vice President of the UDI Practice at USDM Life Sciences, Crowley helps medical device manufacturers achieve regulatory compliance as well as internal benefits and competitive advantage with UDI implementation. The FDA UDI Final Rule requires that most medical devices distributed in the United States carry a unique device identifier, or UDI.
Crowley held various positions over nearly 27 years at the FDA. Most recently, he was Senior Advisor for Patient Safety, in FDA's Center for Devices and Radiological Health. Crowley had primary responsibility for the development and implementation of the FDA's Unique Device Identification System.
Implementation of a UDI System: A Focus on US FDA Rules is at the Sheraton Brussels Airport Hotel in Brussels, Belgium on May 15th from 9:30am - 4:30pm.
About USDM Life Sciences:
USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services via project teams and staff augmentation to our clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. USDM Life Sciences has more than 14 years of experience supplying our clients in the life science industry with compliance services during each phase of their drug and product development cycle while partnering with best of breed organizations to help companies simplify, unify and optimize their business and compliance objectives. For more information, please visit www.usdm.com.