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Graduate Course Proposal Form Submission Detail - EIN6275
Tracking Number - 1882

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Current Status: Approved, Permanent Archive - 2005-05-04
Submission Type:
Course Change Information (for course changes only):

Detail Information

  1. Date & Time Submitted: 2005-01-20
  2. Department: Industrial and Mangement Systems Engineering
  3. College: EN
  4. Budget Account Number: 2103-000-00
  5. Contact Person: Prof. Dolores K. Gooding
  6. Phone: 45582
  7. Email:
  8. Prefix: EIN
  9. Number: 6275
  10. Full Title: Design Controls for Medical Devices
  11. Credit Hours: 3
  12. Section Type: C - Class Lecture (Primarily)
  13. Is the course title variable?: N
  14. Is a permit required for registration?: N
  15. Are the credit hours variable?: N
  16. Is this course repeatable?:
  17. If repeatable, how many times?: 0
  18. Abbreviated Title (30 characters maximum): Design Controls Med Dev
  19. Course Online?: -
  20. Percentage Online:
  21. Grading Option: R - Regular
  22. Prerequisites: Overview Regulated Industries or by permission of Instructor
  23. Corequisites: None
  24. Course Description: The course provides students with information to establish procedures to effectively control the design requirements and specifications for medical devices. The design process will be examined to apply the best approaches for verification and validation.

  25. 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 integrity of the design requirements and design specifications processes will be discussed.
  26. 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.
  27. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times? No. This course has not been offered previously.
  28. 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.

  29. Objectives: The course provides students with information to establish and maintain procedures to effectively control the design requirements and specifications for medical devices. Each phase of the design process will be examined to apply the best approaches to ensure design input requirements and design output specifications are in alignment.
  30. Learning Outcomes: At the end of the course the student will: Develop and maintain an effective design control system; Describe the phases of design: planning, input, output, verification, validation, transfer and changes; Develop the components of a design history file and effectively maintain such; Perform software validation and product risk analysis;
  31. Major Topics: Design input or requirements identification; Design output or specifications development; Design test process for verification; Design test process for validation; Software validation process; Device design to production specifications transferal; Risk analysis; Design changes during the design process; Post-market product design changes;
  32. Textbooks: Practical Design Control Implementation for Medical Devices; Author: Jose M. Justiniano, Venky Gopalaswamy; Publisher: CRC Press; Reference website:;
  33. Course Readings, Online Resources, and Other Purchases:
  34. Student Expectations/Requirements and Grading Policy:
  35. Assignments, Exams and Tests:
  36. Attendance Policy:
  37. Policy on Make-up Work:
  38. Program This Course Supports:
  39. Course Concurrence Information:

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