THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
Watch now: Use-Related Risk Analysis Q&A
Our Emergo by UL experts answer use-related risk analysis (URRA) questions in this open forum.
Webinar date
Nov. 18, 2025
Speakers
Merrick Kossack, Senior Research Director, HFR&D
Frauke Schuurkamp, Managing Human Factors Specialist
Rachel Aronchick, Managing Human Factors Specialist
URRA: The foundation for your human factors engineering activities
Conducting a use-related risk analysis (URRA) is one of the most important steps when applying human factors engineering (HFE) during development of your medical device or combination product. This is understandable since your goal is to develop a product that is safe and effective to use.
Your use-related risk analysis will be key in determining if you achieve this objective. Whether it’s helping to determine user interface requirements, the scope of your HF validation efforts or whether the device has acceptable residual risk, the URRA is the foundation for your most critical HFE activities. Given its importance, it’s no wonder you might have questions about performing this key activity. We can help you with some of those questions.
During this session, we share our insights on questions regarding such use-related risk analysis topics as:
Strategies for starting a URRA
Handling nuanced situations and edge cases in your URRA
Linkages between the URRA and usability testing
Regulatory expectations for URRAs (e.g., FDA guidance, ISO 14971)
Updating the URRA throughout your development effort
Our presenters
RELATED SOFTWARE
Explore our human factors software platform, OPUS™
OPUS offers a wide variety of training, tools, templates and regulatory guidance to help you stay ahead in your HFE activities.
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TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more. Stay informed with actionable insights on the topics you choose, delivered directly to your inbox.
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