Human Factors/Usability (HFE/UE) Engineering is the application of data and principles from the behavioral sciences to the design of products to make them safe, effective, efficient and easy to use. Regulators require the application of HFE/UE in the design and evaluation of medical devices. Failure to comply with increasingly stringent HFE/UE requirements has led to recent rejections of medical device application submissions and audit observations during design control inspections.
This RAPS Webcast will give an overview of HFE/UE applied to medical products, explain the regulatory requirements and describe the role of the latest standards, including AAMI HE-75 and IEC 62366. Following this overview, a description of usability testing processes, such as user interfaces simulated use testing, will be discussed. Additionally, this webcast will evaluate the importance of “concurrent engineering,” with quality, regulatory, clinical, production and service teams in development of products.