Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination product manufacturers face some unique challenges because their products are subject to HFE requirements for devices, drugs, cosmetics, or more. In this webinar, we will provide an overview of HFE considerations for combination products. You will learn:
- Introduction to Human Factors Engineering (HFE)
- Regulatory imperative for applying HFE (per FDA, IEC 62366, MHRA)
- Combination product specific guidance for new drugs, generics, and interchangeable biosimilars
- Key HFE tasks and estimated timelines
- Case studies and lessons learned
ABOUT THE PRESENTER
Frauke Schuurkamp received her B.S. in Applied Psychology from the Saxion University of Applied Sciences and her M.S. in Human Factors & Media Psychology from the University of Twente. After completing her human factors training she joined the HFRD team, where she contributes to user research and usability testing projects.