In this conclusive installment we explore the intricacies of AAMI HE75:2009 and its implications for medical device development. As you know, the FDA, AAMI, and the entire medical device development community are steadfast in their commitment to prioritizing usability research, human factors, and device ease-of-use. This commitment has led to the continuous evolution of standards and guidance documents, with AAMI HE75:2009 standing as a cornerstone in this landscape.

During Episode 4, we meticulously dissect this guidance document, offering invaluable insights into its usability research and development methodologies. Our aim is to empower medical device developers with the knowledge they need to craft well-designed, safe, and effective medical devices that align with FDA regulations.

This episode provides an opportunity to gain a deeper understanding of the principles and practices that underpin human factors engineering, ultimately driving innovation and enhancing patient outcomes.