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Medical Device Life-Cycle Management
A required course in the Certificate Program in Medical Product Development .
Course Description
From concept through development to approval, the Medical Device Life Cycle integrates design, development, validation, and commercialization. Further your understanding of the phases, requirements, and deliverables of the Device Life Cycle in order to manage projects and multifunctional teams. Topics covered include Product Development Process, Customer Requirements, Proof of Concept, Design Control, Design Verification and Validation, Design Transfer, Product Launch, Risk Management, regulatory strategy, intellectual property management, project management, start-up company experiences, and time to market.
Recommended prerequisite: EECS_X445.2, Regulatory Requirements for Medical Devices or equivalent experience.
Instructor
Todd Cushman, MBA, is the CEO of Bioness, INC. as medical device company that develops products to treat central nervous system disorders. In 1985, he founded Acumed, a developer of surgical technologies that was acquired by Medtronic in 1999. He has expertise in new product development, manufacturing, marketing, FDA regulatory and clinical affairs. He often lectures at conferences and medical trade meetings in addition to consulting for companies in the medical device industry.
Textbook Information
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
No textbooks are required for this course.
Meeting Schedule
Event Date Day Start Time End Time Location Room
START 04/03/2023 Monday --- --- Online (Access Begins) ---
END 06/11/2023 Sunday --- --- Online (Access Ends) ---