This course provides an overview of the Food and Drug Administration (FDA) principles, requirements, and expectations for compliance with the Current Good Manufacturing Practices (CGMPs) related to medical device manufacture. Discussions of ISO standards and their application to the marketing of medical devices include an introduction to ISO certification and the similarities to Quality Systems Regulations (QSR). The importance of Good Documentation Practices with respect to CGMP compliance will be stressed. FDA enforcement and consequences of non-compliance will be addressed.