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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.
The European MDR and Human Factors Engineering: Evaluation of User Interface of Unknown Provenance (UOUP)
How medical device manufacturers can determine whether they qualify for UOUP designation in order to demonstrate conformity to IEC 62366, which is necessary for European MDR compliance.
Continuing to make progress on human factors work during the COVID-19 pandemic
Tips and recommendations for how to continue critical HFE and usability studies for medical devices while maintaining social distancing and remote work. Learn more at Emergo by UL's Human Factors Research & Design unit.