Graduate Studies Reports Access
Graduate Course Proposal Form Submission Detail - EIN6274
Tracking Number - 1883
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Approved, Permanent Archive - 2005-05-04
Course Change Information (for course changes only):
- Date & Time Submitted: 2005-01-20
- Department: Industrial and Mangement Systems Engineering
- College: EN
- Budget Account Number: 2103-000-00
- Contact Person: Prof. Dolores K. Gooding
- Phone: 45582
- Email: email@example.com
- Prefix: EIN
- Number: 6274
- Full Title: Human Factors Engineering in Medical Devices
- Credit Hours: 3
- Section Type: C -
Class Lecture (Primarily)
- Is the course title variable?: N
- Is a permit required for registration?: N
- Are the credit hours variable?: N
- Is this course repeatable?:
- If repeatable, how many times?: 0
- Abbreviated Title (30 characters maximum): Human Factors Engr Med Dev
- Course Online?: -
- Percentage Online:
- Grading Option:
R - Regular
- Prerequisites: Overview Regulated Industries or by permission of Instructor
- Corequisites: None
- Course Description: The course provides students with information for the ergonomic design and operability of medical devices. These systematic designs are critical in improving the safety of medical devices by reducing the probability of user error.
- Please briefly explain why it is necessary and/or desirable to add this course: This course teaches a vital component of regulatory affairs specifically in medical device manufacturing environments. Major topics related to the integration of ergonomic principles in medical device design to reduce the potential of human error during u
- What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service? This course serves as an elective in the MS in Engineering Management program, and MS and PhD programs in Biomedical Engineering. It is also a required course in the Graduate Certificate in Regulatory Affairs.
- Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times? No. This course has not been offered previously.
- What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.) The instructor should possess the following qualifications at a minimum:
A master's degree in Industrial Engineering or other technical discipline, plus experience in a relevant technical environment with a focus in regulatory affairs. An individual with an earned PhD with the above listed expertise is preferred.
- Objectives: The course provides students with information for the ergonomic design and operability of medical devices. These systematic designs are critical in improving the safety of medical devices by reducing the probability of user error.
- Learning Outcomes: At the end of the course the student will: Understand how the medical device design, the operating environment, and the user interact; Describe the safety aspects of control/display arrangements; Identify the most appropriate methods to be used for hazard analyses; Describe the development of prototypes and scenarios to perform usability testing;
- Major Topics: The Interaction of Users, Design, and Operating Environment; Design Implications; The User Interface; Control/Display Arrangement and Design; Device Logic and Micro-processing; Component Installation; Alarms; Usability Testing;
- Textbooks: Medical Device and Equipment Design: Usability Engineering and Ergonomics; Author: Michael E. Wiklund; Publisher: CRC Press; Reference website: http://www.fda.gov/cdrh/humanfactors/;
- Course Readings, Online Resources, and Other Purchases:
- Student Expectations/Requirements and Grading Policy:
- Assignments, Exams and Tests:
- Attendance Policy:
- Policy on Make-up Work:
- Program This Course Supports:
- Course Concurrence Information: