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 is unfamiliar territory – made even more challenging without in-house testing facilities or prior experience. The result? Costly delays, additional validation studies, and incomplete files that stall approval.

Eurofins Medical Device Services network of laboratories partners with you to navigate the regulatory path. 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:

• Identifies and characterises use-related hazards and potential harms
• Accounts for known use problems, complaints, and predicate device data
• Considers real-world use environments (lighting, noise, urgency, stress, etc.)
• Evaluates user capabilities and limitations in context
• Outlines design mitigations for critical tasks
• Aligns with human factors testing

We apply industry-standard methods such as Task Analysis, PCA, Failure Modes and Effects Analysis, and Fault Tree Analysis, ensuring your documentation meets FDA CDRH guidance and international best practice.