Fundamentals of Medical Device Engineering

BIOENGR X 430.1

This course introduces the challenges and opportunities for creative, impactful medical device engineering that meets FDA regulation.

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What you can learn.

Gain an overview of medical device design and engineering to meet FDA regulations
Address quality assurance and control practices in developing medical devices to meet product requirements
Identify, plan, and control risk aspects inherent to the medical device field
Realize industry special considerations for product safety in a regulated environment

About this course:

This course introduces the challenges and opportunities for creative, impactful medical device engineering that meets FDA regulation. It includes examples of current device development and identifies the medical and technical frontiers of this industry. Quality considerations and risk management are a part of the FDA mandated design process. This course illustrates how this constraint is not an obstacle but an opportunity to compete on the basis of meaningful product features and reliability. Upon completing this course, the student gains a broad exposure to this industry and understands the special considerations regarding engineering for product safety in a regulated environment.