BMEN6331 - Regulation of Medical Devices and Diagnostics

BMEN 6331 Regulation of Medical Devices and Diagnostics (3 semester credit hours) This course defines medical devices and introduces the historical background of relevant regulations, the organizations that regulate these products, and the pre-market, post-market, and sustaining design, manufacturing, clinical, reimbursement, regulatory, marketing and quality activities and practices required for compliance. This course covers both U.S. and international Medical Device Regulation. (3-0) Y