Focus of the course is compliance requirements necessary for Good Manufacturing Practices and Quality Management System. Background includes familiarization of the different categories of medical devices and their manufacturing special requirements. Manufacturing facility requirements are then presented, noting major differences between the various classes of medical devices and also within the classes (e.g. sterility requirements or cleanliness). Included are special requirements for combination products. Regulatory requirements are reviewed. The core of this course is the good engineering practices of facility design. This includes conceptual design, basic engineering, scale up (from lab to manufacturing), procurement, construction, key technologies such as HVAC and utilities requirements, and commissioning, qualification, and validation. Calibration, re-qualification, and maintenance are covered for optimal operational efficiency. Case studies of various manufacturing facilities will be presented.