What is a Use Related Risk Analysis (URRA)?
A Use-Related Risk Analysis (URRA) in medical device design is a structured process that focuses on identifying and mitigating risks associated with how users interact with a medical device. Conducting and documenting this analysis ensures that the device meets FDA and ISO standards for usability and safety by addressing use-related risks early in the design process.
Tips on writing a URRA:
There's an art to user related risk analysis. Below are four actionable steps to help you make progress in the right direction.
Identify critical tasks and user interactions: Begin by listing all key tasks users must perform when interacting with the medical device, focusing on tasks where errors could occur.
Assess potential hazards and risks: For each task , document potential hazards, user errors, and associated risks. Evaluate the likelihood and severity of harm associated with the unmitigated risks.
Propose mitigation measures: For each identified risk, recommend design improvements, user instructions, or safety features to reduce or eliminate the likelihood of errors and their impact.
Track and review risk levels: Update the URRA template as risks are mitigated, and reassess the overall risk level to ensure that remaining risks are acceptable, adhering to safety standards and regulatory requirements.
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GOT QUESTIONS?
FAQ About Use Related Risk Analysis
Here are some answers to frequently asked questions about Use Related Risk Analysis.
How is URRA different from Risk Hazard Analysis?
What are the key components of URRA?
How does URRA integrate with Human Factors Engineering (HFE)?
Why is URRA important in the development of medical devices?
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