The Use-Related Risk Analysis (URRA) is a vital tool in the human factors (HF) engineering process. It should be integrated into the overall risk management framework. URRA assesses potential hazards and harms linked to using a medical device. Additionally, it examines user interactions with the device interface, environmental factors, and device characteristics. By doing so, it identifies and mitigates foreseeable use errors that could lead to harm.
Why do I need URRA?
URRA is essential to the design process because it identifies potential hazards that could compromise safety. It focuses on the user, patient, or environment when the device is in use. By systematically assessing user interactions and environmental factors, URRA guides the design team in mitigating risks. Additionally, it informs HF study design and ensures the device meets regulatory requirements. Ultimately, it enhances both usability and user safety.
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