The European MDR and Human Factors Engineering: Designing User-friendly Software User Interfaces
Emergo by UL’s Human Factors Research and Design team has extensive experience developing software user interfaces and instructional materials for various medical devices.
Latest Insights on FDA Expectations from the 2020 Virtual HFES Health Care Symposium
FDA recognizes the constraints that COVID-19 has placed on in-person testing, but emphasized the importance of seeking
Design Verification and Validation Versus Human Factors Validation
In the complex world of medical device regulation, it can be difficult to keep things straight when it comes to product development.
Virtual Comfort: The Key to Successful Remote Usability Testing
How and what to provide usability test participants to obtain reliable and valid results in an era of remote and virtual interactions. Learn more at Emergo by UL's Human Factors Research & Design.
Usability Considerations When Creating a “Go Baby Go” Car
A robotics project to help children with mobility issues offers practical lessons in human factors engineering (HFE) design.
"Rushing Slowly" to Market: Applying Human Factors to Fast-tracked Medical Products
Keeping human factors engineering and usability considerations front and center when seeking expedited emergency market access for medical devices and technologies.
10 Steps to Conducting a Use-related Risk Analysis as Part of Your Human Factors Engineering Process
Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US FDA and international reviewers.
Handling Incidental Findings in Human Factors Research
In the course of research, the chance exists of encountering results unrelated to your study that potentially impact the lives of participants. How should you respond to such events, and how can you and your team prepare for them?
The European MDR and Human Factors Engineering: Use-related Risks
As with the European Medical Devices Directive (MDD), the MDR expects usability engineering to be incorporated into the overall risk management and device development process.
Has FDA Relaxed Its Human Factors Expectations in Response to the COVID-19 Pandemic?
There are several key activities required by the US Federal Drug Administration (FDA) to meet its expectations for the application of human factors (HF) engineering to medical devices.