Application of Quality System Regulation in Medical Device Design and Manufacturing

RGA 6233 4 Quarter Hours
Course Level CPS - Graduate
Description Introduces the Food and Drug Administration’s (FDA) Quality System Regulations (QSRs) and describes how these regulations can improve the safety and efficacy of medical device products. Discusses the legislative origins of QSRs, their historical evolution, as well as the details of how they are implemented. Examines case studies and empirical examples of QSRs that have been employed by individual medical device manufacturers during the product commercialization process. Offers students an opportunity to develop an understanding of FDA’s expectations for product design control; the structuring of quality system documentation; and principles of practical QSRs within the context of medical device manufacturing, packaging, and distribution. Encourages students to develop strategies for customizing QSRs to particular companies, device products, and manufacturing environments.


Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.


Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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