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Addressing potential usability issues early in the human factors engineering (HFE) process can save your team time and money over the course of development while providing evidence of a robust human factors process to regulatory agencies. Cognitive walkthroughs are a powerful method to identify potential usability issues in early development stages when initial decisions about design directions ..

We all know the chicken or the egg causality dilemma, often introduced as “what came first, the chicken or the egg?” You could pose a similar question for risk control measures referenced in HF validation tests: What comes first, the verification of use-related risk control measures or the HF validation test?   When to Verify Risk Control Measures | Emergo by UL When to Verify Risk Control Measu..

The U.S. Food and Drug Administration (FDA) issued a new draft human factors engineering (HFE) guidance document, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, on July 8, 2024. The guidance informs manufacturers of drug- and biologic-led combination products about the purpose and content of a use-related risk analysis (URRA) and how a ..