Course Offerings

This course provides a broad overview of the United States Food and Drug Administration (FDA) principles, requirements, and expectations for compliance with the Current Good Manufacturing Practices (CGMPs) for medical device manufacturing. We will review the regulatory definition of medical devices and the divisions of FDA that oversee medical device applications and compliance. Participants will learn how the risk-based categorization of medical devices affects the scope of CGMPs for these products. Discussions of ISO standards and how they apply to the marketing of medical devices internationally will provide perspective on the US regulations as well as inform those considering market expansion. These discussions will include an introduction to the process of ISO certification and the similarities to Quality Systems Regulations (QSR). Hands-on activities will provide students with direct experience utilizing the FDA website to access regulatory and guidance information as well as previous regulatory actions the FDA has taken concerning medical device compliance. Additional exercises will demonstrate the application of design control, verification, and validation principles.