This 21-hour course meets one day per week for 3 hours, over a 7-week period. A thorough examination of FDA regulations and an overview of equivalent international regulations will be covered. As a result of this training students will be able to describe the mission and organization of the FDA; locate the current laws and regulations that regulate the medical device industry; propose a corrective and/or preventive action to a not-compliant issue in the medical device industry; describe the different classifications for medical device products and the pre-market pathway appropriate for each device classification; and explain the value of post-market requirements for approved devices (ISO 13485:2016)