BME416syllabus_2008 - Development and Regulation of Medical...

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Development and Regulation of Medical Products - BME 416 Syllabus – 2008 Spring Semester Gerald E. Loeb and Enid Rokaw 1. Basic Information Course name : Development and Regulation of Medical Products Units: 3 Place and time: OHE 122 (DEN Studio), Fridays 2:00-5:00PM Faculty: Gerald Loeb, MD, Department of Biomedical Engineering [email protected], 213-821-1112, DRB B12 Most days between 10-6; email or telephone in advance Enid Rokaw, M.Sc., Regulatory Science Program [email protected], HSC: CHP G32 TA: Dan Song, [email protected], 530-220-3226, DRB B23 Textbook: Bringing Your Medical Device to Market, Ed. J. B. Reiss, 2nd ed., 2006, Food & Drug Law Institute, Washington, DC 20005 2. Course Goal and Learning Objectives 2.1 Goals: BME 416 is designed to introduce you to the world of medical product development. Medical devices, drugs and diagnostics are highly regulated products. Special measures are associated with developing safe and effective products for humans and animals and these affect the way that biomedical industries are structured and operate. To be successful in such environments, the biomedical engineer should understand the rules and regulations that govern the design, fabrication and maintenance of medical products. He or she should also know how other aspects of the business affect the environment in which the engineer must work. 2.2 Course Objectives: After completing this course, you should be able to: Describe the typical structure and goals of different departments in a biomedical business, and recognize when individuals from these departments should be involved in decisions about medical product development
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