Course Information for 3801 - bioDesign I
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Primary Instructor: Kelly W. Broadhead
Designation:Required
Credits: 3.0
Semesters Offered:Spring
Frequency Offered:Annual
Prerequisites:Major status or department approval
Class Schedule: Tue and Thur 10:45 to 12:05
Catalog Description: First semester of a two semester capstone biomedical engineering design class covered from the perspective of FDA design mandates. Students will design and prototype a medical device using FDA requirements for Design Control. All projects will be planned, managed and executed using FDA Design Control Requirements. To accomplish this, projects will utilize customer driven inputs to motivate the development of product specifications. Prototypes will be fabricated based on these specifications. The prototypes will be tested and evaluated to ensure the specifications are met. All projects will be implemented using a planned, multidisciplinary, ethics-based team approach. Students will also choose whether they will use their design project or an outside project for their senior project class and will provide a written and oral project proposal for their senior project. Lecture: 2 hours and Lab: 3 hours.
Required Texts:FDA 21CFR820: Title 21--Food and Drugs, Subchapter H - Medical Devices, Part 820 Quality System Regulation (available on the web at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820&showFR=1)
Optional Texts:Design Controls for the Medical Device Industry, Marie B. Teixeira and Richard Bradley, Marcel Decker, Inc. 2002. ISBN:0-8247-0830-X or (alternative) Design of Biomedical Devices and Systems, 1st Edition, P.H. King and R.C. Fries, Marcel Decker, Inc., 2003. ISBN:0-8247-0889-X
Course Website: www.bioen.utah/design
Course Syllabus:Syllabus_3801.pdf