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BME 410. FDA and ISO Requirements for the Development and Manufacturing of Medical Devices. 3 or 4 hours.

FDA Performance Standard for General Medical Devices for manufacturing and development engineers. Product requirement definition, design control, hazard analysis, failure mode and effect analysis, regulatory submission, product tests, ISO 9001. Course Information: 3 undergraduate hours. 4 graduate hours. Previously listed as BIOE 410. Prerequisite(s): BIOE 250 or BME 250; and junior standing or above.