Understanding ISO 13485:2003

Course gives students a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485:2003. The course focuses on teaching the process approach for quality management and how ISO 13485:2003 and GMPs compliment each other. In addition, students gain an introduction to the concept of risk management as described in the standard ISO 14971:2007, “Application of Risk Management to Medical Devices.” The course includes exercises to provide students with the opportunity to practice the information taught in the course. Our instructors also encourage discussion and debate as part of the learning process. (0.8 CEUs)

08SI22000 Sep 15 (M, 8am-5:30pm)

$995