News and Insights

Core is excited to announce we have a new article published on  Med Device Online ! Seda Japp, an associate at Core HF, authored a thoughtful analysis, explanation, and critique of methods for calculating sample sizes for various human factors studies.

Best Practices for Creating and Updating your HFE/UE File At Core Human Factors, our clients often reach out to us with questions regarding their human factors engineering / usability engineering file (UE file). Guidances and standards from both domestic and international regulatory bodies reference a wide array of studies, methods, and documents that can be a part of your human factors design process depending on your needs and your product’s risk profile. Determining which methods to utilize can be challenging, and understanding how to structure a UE file can be confusing and difficult.