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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.

  • Details
  • $735
  • September 27, 2021 to December 05, 2021
  • Delivery Mode: Online
  • Reg#: 00201
  • ID/Units: BME X408  (3.00)
    ( Section 1 )
  • Quarter: FALL 2021

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

EventDateDayStart TimeEnd TimeLocationRoom
START09/27/2021Monday------Online (Access Begins)---
END12/05/2021Sunday------Online (Access Ends)---