This course covers technical and managerial aspects involved in the development of medical devices and diagnostics through a combination of lectures, classroom labs, and a team design project. Students will solve specific tasks from the perspective of a product manager, development engineer, industrial designer, or manufacturing engineer. Related aspects of market research, quality control, and the FDA approval process are emphasized in other complementary courses at KGI. The design project leads students through: (a) preparation of a problem statement and product design specification; (b) design and prototyping; (c) testing; (d) design for manufacture and assembly; and will conclude with (e) the preparation of a device master record. Specific technical skills necessary for the team project are each introduced using a combination of a concept video, brief lecture, and classroom lab. Students will receive an overview of general industry standards, quality systems, and certification processes.
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