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| BME 5304 - BME Device Design & Regulation |
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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.
3.000 Credit hours 3.000 Lecture hours 0.000 Lab hours 0.000 Other hours Levels: Graduate Schedule Types: Lecture (LECT) Course Fee(s): None. College of Engineering (Dean) Department |
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