In the concluding episode of our series, “Recommended Principals and Practices for Human Factors Engineering,” we explore the intricacies of AAMI HE75:2009 and its significant influence on medical device development. This document, recognized as a cornerstone by the FDA, AAMI, and the broader medical device community, guides the prioritization of usability research, human factors, and ease-of-use in designing medical devices.

Episode 4 provides a comprehensive analysis of AAMI HE75:2009, offering valuable insights into its methodologies for usability research and development. Our objective is to equip medical device developers with essential knowledge to create safe, effective, and well-engineered devices that meet FDA regulations.

Join us to gain a deeper understanding of the foundational principles and practices of human factors engineering, ultimately driving innovation and improving patient outcomes.