Increase your understanding of the essential U.S. medical device regulations, including organizing pre-market notification 510(k), device classification, and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, global vigilance requirements and labeling requirements, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Australia, Canada, Latin American and Japa.