Andrea Sutton is a Research Director with Emergo by UL’s human factors team. She has been with the team since 2010. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying HFE during medical and drug delivery device development. She helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses, and guides clients in engaging with the FDA on clients’ HFE strategies. She frequently conducts workshops, speaks at industry events and advises clients on how to implement HFE in the medical device development process. Andrea is a co-author of Medical Device Use Error – Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.
On-demand webinars
- Knowledge Task Testing to Validate Instructions and Warnings
- Best Practices for Engaging with the US FDA on Human Factors Strategy
- Open Forum: Human Factors Usability Testing Q&A
- Bringing Medical Devices Home
- Latest FDA Expectations for Conducting Human Factors Validation Tests of Combination Products