Date & Time
Starts
Nov 18, 2025 9:00am CST
Ends
10:00am CST
Location
Online
Language
English
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 will share our insights on your live or pre-submitted questions regarding use-related risk analyses.
Depending on the questions received, our discussion may cover topics including, but not limited to:
- Strategies for starting a URRA
- Handling nuanced situations and edge cases in your URRA
- Linkages between the URRA and usability testing
- Updating the URRA throughout your development effort
- Regulatory expectations for URRAs (e.g., FDA guidance, ISO 14971)
Don’t miss the chance to connect with Emergo by UL’s Human Factors Research & Design team.
Please submit your questions ahead of time to emergomarketing@ul.com or during the webinar.
Our presenters
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Please submit your questions in advance to emergomarketing@ul.com or during the webinar.