RGA 6630 — Medical Device Quality Management System: Principles and Applications
3 semester hoursGraduateLecture
Introduces the U.S. Food and Drug Administration’s Quality Management System Regulation and describes how it can improve the safety and efficacy of medical devices. Discusses the legislative origins of the QMSR, its historical evolution from the Quality System Regulation to FDA’s harmonization of the U.S. Current Good Manufacturing Practice regulations with global quality management requirements, as well as the details of how QMSR is implemented. Examines case studies and real-world examples of applications of quality management system requirements by medical device manufacturers during the product commercialization process. Studies regulatory expectations for product design control and the structuring of QMSR documentation. Encourages students to develop strategies for customizing QMSR to particular companies, products, and manufacturing environments.