Preparing for Human Factors Engineering Meetings with US FDA Checklist
Emergo by UL human factors specialists share a checklist that is convenient when one is preparing for and participating in meetings with the U.S. FDA regarding human factors strategy.
Human Factors Considerations for Medical Devices Used by Older Adults
This article explores the current landscape of how older adult users might interact with technology, particularly those in the healthcare space.
Japan regulators MHLW/PMDA require compliance with HFE/UE standard
As of April 1, 2024, the Japanese regulatory authorities, the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Products Agency (PMDA) require compliance with JIS T 62366-1:2022, Japan’s national Human Factors Engineering (HFE)/Usability Engineering (UE) standard for medical devices.
Frauke Schuurkamp
Open Forum: Human Factors Usability Testing Q&A
During this interactive session, our senior HFE experts answered pre-submitted and live questions about conducting usability testing of medical devices.
Summary of FDA’s July 2024 Draft Guidance on URRAs
Emergo by UL's Human Factors Specialist provides insights into the FDA's July 2024 draft guidance on the purpose and content of Use Related Risk Analysis (URRAS)
Noteworthy Strategies: Optimizing Data Collection During Complex System Usability Tests
Learn strategies for high-quality data capture in complex systems usability tests. Discover tips on structuring data collection tools, setting up test environments and synthesizing data.
Some Assembly Required: Unique Considerations for Applying Human Factors to a Medical Products System
Emergo by UL human factors specialists discuss how to apply human factors engineering to medical products as a system.
Validate Smarter, Not Harder: Exploring the Scope of Critical Tasks in an HF Validation Test
Discover efficient approaches to streamline HF validation testing for medical devices. Learn about alternative methods, regulatory insights and best practices from Emergo by UL.
Conducting a Comparative Analysis in Lieu of HF Validation Testing
Learn how to conduct effective comparative analysis as an alternative approach to HF validation testing.