BME 274 - Regulatory, Clinical and Manufacturing Aspects of Medical Devices

3 units
FDA regulations related to medical devices; planning and implementation of clinical trials; sterilization techniques; failure mode analysis; quality control for medical device manufacture; intellectual property; field trips to device manufacturers.

Satisfies GWAR: Graduation Writing Assessment Requirement.

Prerequisite(s): BME 115, Graduate standing; or instructor consent.
Grading: Letter Graded

Note(s): This course satisfies graduate-level GWAR in this master’s program.

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