Understanding and applying human factors is essential to ensuring product usability and user satisfaction. More importantly, consideration of human factors during the design and development of medical devices helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation each week to cover core concepts and demonstrate how human factors fit into the larger context of medical device software and hardware development. Lessons address the integration of human factors and usability into the product development lifecycle, regulatory considerations, including applicable FDA guidance and standards (ANSI/IEC), and human factors methods.
The course is beneficial for professionals who already have a basic understanding of risk management and quality systems, as well as a broad range of technical professionals, including those with no prior medical device experience.