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Graduate Course Proposal Form Submission Detail - EIN6276
Tracking Number - 1881

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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: 6276
  10. Full Title: International Regulations 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): Int'l Regulations 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 regarding the major global compliance issues related to medical devices. The initiatives of the Global Harmonization Task Force to facilitate international trade without compromising safety will be explored.

  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 medical device regulation in major international markets will be explained, along with the various initiatives t
  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 regarding the major global and region-specific compliance issues related to medical devices. The similarities in regulatory requirements will be discussed, and the initiatives of the Global Harmonization Task Force to facilitate international trade without compromising quality and safety will be explored.
  30. Learning Outcomes: At the end of the course the student will: Understand the history and current structures of the regulatory agencies in major international markets; Describe the product approval process in international markets and the nature of agreements among regulatory agencies; Describe the composition of the Global Harmonization Task Force (GHTF) and contributions to facilitate international trade; Explain the requirements of ISO13485, and CE markings;
  31. Major Topics: Quality assurance and the current international regulations; Focus on international markets by region (EU, Canada, Australia, Asia); Responsibilities of the international regulatory affairs specialist; Standardization; Clinical Trials Role in Approval Process; CE Marking; Global Harmonization Task Force Documents; Global Product Development Strategies;
  32. Textbooks: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety; Author: Gordon R. Higson; Publisher: Institute of Physics Publishing; 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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