Fundamentals of Medical Device Engineering

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.