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Oct 28, 2024
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BMED 2100 - Design and Manufacturing in the Medical Device Industry
Credits: 3
This course provides an introduction to the design and manufacturing of medical devices with special focus on the unique design manufacturing challenges that are necessary to achieve World Class Manufacturing (WCM) excellence. The course describes the fundamental systems used in the design, development, and manufacturing of medical devices and how these relate to industry regulations. Specific topics include: material and process selection considerations, aseptic processes, clean-room techniques, sterilization processes, clinical testing, lot traceability, introduction to automation and control systems, testing and instrumentation lab and manufacturing controls. BMED 1100 is strongly recommended as a first class for those with no previous biomedical device industry experience.
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