MEDICAL DEVICES ECOSYSTEM: THE PATH TO PRODUCT
BME 640
课程描述
Development of medical devices for therapeutic or diagnostic purposes. Gap analysis, market analysis, reimbursement/distribution, regulatory approval, and manufacturing/supply chain development. Refinement and presentation of design ideas and corporate strategy within a team setting. Case studies of device design/manufacture including supply chain, intellectual property, pre-clinical testing, U.S. and European regulatory pathways and clinical trial design.
先修课程
BME 402 or concurrent enrollment, graduate/professional standing, or member of Engineering Guest Students
满足要求
This course does not satisfy any prerequisites.
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