(FALL 2009)

A required course in the Certificate Programs in Medical Product Development, and Clinical Trials: Medical Device and Drug Development; and a prerequisite in the Specialized Studies Program in Regulatory Affairs Management.
Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America. Approved for 27 hours of general MCLE credit for eligible participants. See enrollment confirmation for login information.

Dan Modi, M.B.A., RAC, is associate director of product certification and regulatory affairs at Alcon Research Ltd., Irvine Technology Center. He has wide experience in safety certification and regulatory requirements for medical devices. Modi is certified as RAC (Regulatory Affairs Certification), NCE (Certified Engineer by National Association of Radio and Telecommunications Engineers-NARTE) and CQA (Certified Quality Auditor through the American Society for Quality-ASQ).