Conducting a Comparative Analysis in Lieu of HF Validation Testing

A common way to conclude whether a product can be used safely and effectively as intended by the intended users in the intended use environment is to conduct a human factors (HF) validation test. However, it might be appropriate and acceptable to regulators to perform a detailed comparison of a new or modified device against an existing, marketed device to substantiate the new device’s usability and use-safety. 

About our presenters

Petra Boeree, M.S., Senior Human Factors Specialist 
 
Petra Boeree is a Senior Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team. She has been with the team since 2019 and has experience delivering HFE services to the medical device and pharmaceutical industries. Boeree leads and oversees various human factors research activities. She routinely develops use-related risk analyses and test protocols, conducts usability tests, analyzes data, and develops reports that satisfy regulators’ expectations. She holds a B.S. in Applied Psychology from Amsterdam University of Applied Sciences, and an M.S. in Applied Cognitive Psychology from Leiden University.

Emilee Stanczyk, MEM, Managing Human Factors Specialist 

Emilee Stanczyk is a Managing Human Factors Specialist with Emergo by UL’s Human Factors Research & Design (HFR&D) team. She has been with the team since 2016 and has experience delivering HFE services to the medical device and pharmaceutical industries. Stanczyk is involved in leading human factors research, including usability testing, and advises customers on how to apply HFE during product development to meet regulators’ expectations. She holds a B.S. in Biomedical Engineering with a minor in Psychology from Michigan Technological University and a Master’s of Engineering Management from the University of Nebraska.