This course presents validation for medical device manufacturers in terms of its objectives, strategies, planning, protocols, and documentation. Validation requirements include producing, collecting, analyzing, and managing data and documentation in support of medical device product design and product performance claims. These, as well as manufacturing processes and test methods, are presented within the context of current Quality System Regulations (QSR) as well as Risk Analysis. Qualification is addressed for equipment and operational systems, software and automated systems, and facilities for manufacturing medical devices. Validation in all life cycle phases is presented, both prior to commercial production and during the operating life of the plant, process, and product. Case studies are included as specific examples. Through this course, students will understand how to implement validation studies for medical device manufacturers and to evaluate existing studies.