Bioengineering
BIOE 5250: Design, Manufacture, and Evaluation of Medical Devices
Lecture - 4 credits
ND
EI
IC
FQ
SI
AD
DD
ER
WF
WD
WI
EX
CE
- Covers engineering design challenges intrinsic to the development of biomedical devices, including clinical evaluation, manufacture, and testing of medical devices and the constraints that FDA regulations place on these processes.
- Topics include quality systems, design control, cybersecurity concerns, the role of standards in global device regulation, and the design process.
- Students are asked to form teams and to carry out a semester-long conceptual design project to develop a design overview, design plan, design input specifications, and verification test procedures for a novel medical device.
Covers engineering design challenges intrinsic to the development of biomedical devices, including clinical evaluation, manufacture, and testing of medical devices and the constraints that FDA regulations place on these processes. Show more.