Application of Quality System Regulation in Medical Device Design and Manufacturing

Catalog 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.