This eLearning course serves as a guide to ISO 13485:2016 - the international quality management system standard for medical devices. This course serves as a guide to ISO 13485 and discusses the requirements in Clauses 4 through 8 of this standard. The requirements of the standard apply to the methods used in, and the facilities and controls used for, the design and development, production, installation, and servicing of medical devices. In line with the 2016 changes, this course will help learners apply a risk-based approach to the control of the appropriate process needed for the quality management system. Topics in this online training course include: Quality Management System, Management’s Role, Managing Resources, Planning, Design and Purchasing, Production, Monitoring and Analysis, and Improvement. This online learning course also addresses specific aspects of ISO 13485: 2016 as it relates to the European Union (EU). After completing this training course, you will be able to recognize the specific requirements of ISO 13485:2016 and apply them to specific situations.