BIOE5250 (Regulatory and Quality Aspects of Medical Device Design) course reviews and ratings at Northeastern (NEU). Average rating 5.0/5. Compare professors with RateMyProfessor reviews.
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.
Data updated October 2026.