Medical Device Recall or Product Enhancement?


Medical Device Recall
or Product Enhancement?:
Understanding When to
Submit a Part 806

Your office, June 5, 2014


Meet your instructors

Neil O’Flaherty, Principal Attorney, OFLW Law specializes in the area of FDA regulation of medical devices. He has spoken and written extensively on device-related topics. Mr. O’Flaherty’s device work has included assistance to the Advanced Medical Technology Association, the nation’s largest trade association for the medical device industry, including assistance on device tracking, medical software, device reclassification matters and medical device reporting matters. Mr. O’Flaherty was admitted to the Illinois State Bar in 1990 and the District of Columbia Bar in 1991. He is currently a member of the District of Columbia Bar and the Illinois and American Bar Associations. Mr. O’Flaherty is a graduate of the University of Notre Dame and the Loyola University of Chicago School of Law.

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap now works almost exclusively on medical device issues at Olsson, Frank and Weeda (OFW Law) in Washington, D.C.