Webinar Debrief: Developing HFE Strategies to Meet Global Regulations
Debriefing on a recent webinar, Emergo by UL Senior Research Directors share global considerations for cornerstone HFE activities.
Best Practices for Engaging with the US FDA on Human Factors Strategy
Learn how to effectively prepare for and engage with the U.S. FDA via pre-submissions and live meetings focused on a wide range of HFE topics.
A Focus on Usability Testing Protocol Development: Components of Evaluation Activities
Emergo by UL Human Factors Specialists share important components, considerations and examples of evaluation activities (i.e., use scenarios and knowledge tasks) to develop strong usability test protocols, enabling effective test conduct, results and reports.
Top Pen-injector Use Errors and How to Mitigate Them
An Emergo by UL human factors specialist discusses the top use errors observed when evaluating pen-injector interactions during a usability study, and how manufacturers can work towards mitigating such use errors.
How to Conduct a Known Problems Analysis (KPA) for NMPA Compliance
Emergo by UL Human Factors Specialists discuss the specific requirements the National Medical Products Association (NMPA) has set forth for known problems analyses.
Open Q&A forum: Maximizing Human Factors in Early Product Development
Our senior human factors engineering (HFE) and design experts answer questions about how to strategically approach discovery and design activities early on in product development.
Human Factors Research & Design Publications
Gain deep insights into Human Factors Engineering (HFE) and its applications to medical device design by exploring these publications.
Tess Forton
An Exciting Year of Human Factors Engineering (HFE) Regulatory Updates
2024 was an exciting year for Human Factors Engineering (HFE) with regulatory updates from the United States of America’s Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This article provides an overview of these important regulatory updates and highlights resources to help you understand their requirements.
When to Verify Risk Control Measures as Part of Human Factors Engineering Activities
Understand when to verify risk control measures in HF validation testing and how they align with URRA and FDA guidelines for medical devices.