Risk Based Development and Testing of Medical Devices

Catalog description

Credits 4. 2 Lecture Hours. 6 Lab Hours. Focus on the detailed design and development phases of the design innovation process for healthcare applications; includes medical device development projects in which teams will work on innovative medical devices that progressed through the concept phase of the development life cycle; includes detailed design and development, risk based design process, including the conduct of hazards analysis, design FMEA, application FMEA, process FMEA, device manufacturing, device testing and FDA design verification and validation. Prerequisite: Enrolled in master of engineering in biomedical engineering; graduate classification or approval of instructor.