Regulatory Requirements for Medical Devices course

Earn your certificate in Healthcare from University of California, Irvine


Program Title:	Regulatory Requirements for Medical Devices course
Program Level:	Certificate
School:	University of California, Irvine
Program Description:	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.