BME 155 - Safety of Medical Devices (GE, IM)

Institution:

Duke University

Subject:

Biomedical Engineering

Description:

Engineering analysis of the safety of medical devices such as prosthetic heart valves, silicon breast implants, medical imaging, and cardiac pacemakers. Engineering performance standards and US FDA requirements for clinical trials for selected medical devices such as medical diagnostic ultrasound, surgical lasers, and prosthetic heart valves. Students will prepare a mock application for FDA premarket approval to demonstrate safety of a selected medical device. Prerequisite: sophomore standing; corequisite: Physics 62L or equivalent. Instructor: S. Smith

Credits:

1.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

WWW.DUKE.EDU

Phone Number:

(919) 684-8111

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

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