BME Device Design & Regulation

Catalog description

This course introduces the regulatory requirements for the design, testing, and clinical implementation of medical devices and biologics. The first part covers the FDA regulatory process. The second part covers key legal and policy issues involved in a clinical organization: Health Insurance Portability and Accountability Act and Joint Commission on the Accreditation of Health Care Organizations rules on risk management, standards, regulations, compliance and ethics. Prerequisites: BME 5301 or 6301 and BME 5302 or 6302 with a grade of "C" or better; may be taken concurrently. Departmental approval also required. Restricted to level of GR.