Regulatory authorities like the FDA and EMA increasingly expect manufacturers to provide a well-structured Use-Related Risk Analysis (URRA) that accounts for real-world use and user error. But for many companies, identifying the critical tasks, understanding user capabilities, and mapping risk exposure without being overly burdensome is unfamiliar territory - made even more challenging without seasoned professionals with experience meet regulatory requirements in a pragmatic way. The result? Costly delays due to confusing use-related risk documentation and incomplete files that stall approval.

Eurofins Medical Device Services network of laboratories partners with you to develop comprehensive and rigorous use-related risk documentation. Having developed and contributed to URRAs, we have an unmatched understanding of what regulators want to see and what they often find lacking. We build URRAs that are complete, realistic, and easily understood by all stakeholders, from engineers and regulatory teams to FDA reviewers.

Our human factors scientists work closely with your team to develop a comprehensive and defensible URRA that:

• Accounts for known use problems, complaints, and predicate device data
• Builds upon a comprehensive task analysis
• Considers real-world use environments (lighting, noise, urgency, stress, etc.)
• Evaluates user capabilities and limitations in context
• Identifies and characterizes use-related hazards and potential harms
• Identifies critical tasks that could cause harm to a patient or user if not performed correctly
• Outlines design mitigations for critical tasks

We follow all applicable regulatory standards and guidance, ensuring your documentation meets US and international requirements. 

Build a clear, compliant Use-Related Risk Analysis.