The Human Factors foundation course is a rapid-fire introduction to critical human factors processes and why they are important. The course includes discussions regarding the required content of human factors information that should be included in FDA medical device regulatory submissions; applying human factors principals in design according to the ANSI/ AAMI HE 75 standard; usability testing best practices; and a high-level review of FDA Human Factors guidance and OUS requirements. The objectives of this foundations are to jump start an in-depth exploration on the importance of an iterative design process incorporating knowledge of the user, the use environment and the use scenarios which could impact device design. This foundation course also ties use-related risk to design and provides a robust introduction to usability testing. There are hands-on activities which utilize case studies. Join us for this discussion-based interactive training.