In this episode, Greg Montalbano, Co-Owner of MIDI takes us on a deep dive into the details as related to the FDA Perspectives on Human Factors and Device Development. We cover topics related to understanding Regulatory Requirements and Methods for Human Factors Usability Testing such as:

• Why is FDA concerned about Human Factors Engineering and Usability

• What is expected of medical device developers from the FDA

• Specific medical device Human Factors Engineering example relative to hazards, risks and the use related causes.