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Graduate Course Proposal Form Submission Detail - EIN6276

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

  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    1881 2005-01-20
    Department College Budget Account Number
    Industrial and Mangement Systems Engineering EN 2103-000-00
    Contact Person Phone Email
    Prof. Dolores K. Gooding 45582

  2. Course Information

    Prefix Number Full Title
    EIN 6276 International Regulations for Medical Devices

    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

    Credit Hours Section Type Grading Option
    3 C - Class Lecture (Primarily) R - Regular
    Abbreviated Title (30 characters maximum)
    Int'l Regulations Med Dev
    Course Online? Percentage Online


    Overview Regulated Industries or by permission of Instructor



    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.

  3. Justification

    A. 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

    B. 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.

    C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?

    No. This course has not been offered previously.

    D. 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.

  4. Other Course Information

    A. 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.

    B. 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;

    C. 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;

    D. 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:;

    E. Course Readings, Online Resources, and Other Purchases

    F. Student Expectations/Requirements and Grading Policy

    G. Assignments, Exams and Tests

    H. Attendance Policy

    I. Policy on Make-up Work

    J. Program This Course Supports

  5. Course Concurrence Information

- if you have questions about any of these fields, please contact or