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    Quality & RiskQuality SystemURRA

    Use-Related Risk Analysis

    Analysis of use scenarios to identify potential use errors and their consequences.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    A URRA links tasks, potential use errors, and resulting harms - feeding human factors validation testing and ISO 14971 risk control decisions.
    What the regulation says
    Regulators like the FDA (in their guidance, "Applying Human Factors and Usability Engineering to Medical Devices") and standards such as IEC 62366-1:2015 ("Medical devices - Part 1: Application of usability engineering to medical devices") expect manufacturers to perform a Use-Related Risk Analysis (URRA) to identify potential use errors and their associated harms. This analysis directly informs the design of the user interface and the planning of human factors validation testing, ensuring that risks related to device use are adequately controlled as part of a comprehensive risk management process defined in ISO 14971.

    What this means in practice

    FDA's human factors guidance expects a documented URRA covering critical tasks, with each tested in summative validation.

    Examples

    • A URRA for an insulin pump identifies that incorrect programming due to small screen text could lead to under- or over-dosing, informing a design change to increase font size and add confirmation screens.
    • For a surgical robot, the URRA reveals that a specific control input sequence could be misinterpreted by a surgeon under stress, leading to unintended instrument movement, prompting a revision of the control interface design.
    • In a diagnostic imaging device, the URRA highlights that a complex workflow for data entry increases the likelihood of patient misidentification, leading to a streamlined user interface to reduce this risk.
    Common pitfalls
    • •Failing to link identified use errors directly to potential harms can lead to an incomplete risk assessment.
    • •Not performing a URRA early enough in the design process can result in costly redesigns and delays.
    • •Assuming that expert users will not make significant use errors can lead to overlooking critical safety issues.
    • •Confusing a Use-Related Risk Analysis with a general risk analysis, which broadens the scope beyond user interaction, can lead to inefficiencies.
    • •Neglecting to update the URRA after design changes or post-market surveillance findings can compromise device safety.

    Frequently asked questions

    A Use-Related Risk Analysis specifically focuses on risks arising from user interaction with a medical device, identifying potential use errors and their resulting harms. A general risk analysis, as outlined in ISO 14971, encompasses all potential hazards and hazardous situations related to a medical device's lifecycle, including those not directly linked to user interaction.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·2ISO·1
    1. 1
      FDA Human Factors Guidance
      Verified
      FDAfda.gov
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.