Human Factors/Usability testing is now a requirement. Human Factors/Usability testing is good business and can be easily integrated into product design/development. Human Factors is at the essence of the UseFMEA and hence instrumental in being able to reduce the probability of risk, and even the severity of risk. The key to integrating Human Factors is to understand the activities involved throughout the product development cycle and the corresponding design controls. These activities will be covered with the opportunity to implement on a real world problem/device. In addition, the appropriate documentation and content will be covered so that a full picture of the integration can be understood. Differences between European and US standards will be covered as required.