Navigating regulatory expectations around Human Factors Engineering (HFE), integrating risk mitigation into your processes, and ensuring end-user safety can be a tough balancing act. Eurofins Medical Device Services network of laboratories collaborates with you to ensure your human factors strategy becomes a strength, not a stumbling block. Through design, execution, and reporting, our team develops regulator-ready HFE strategies that integrate seamlessly with your medical device development cycles from early planning to final validation.

Eurofins Medical Device Services supports your journey from start to finish with expert insights and hands-on execution services, including:

• Expert Reviews 
• FDA Meeting Planning
• Gap Analyses 
• Human Factors Integration Plans
• Human Factors Remediation Plans ​
• Human Factors SOPs ​
• Human Factors Strategy
• Labeling Development
• Threshold Analyses 
• ​Use-Related Risk Analysis (URRA)
• Use Specifications ​

Our human-centered testing approach provides confidence at every stage. You’ll gain insights into how your medical device is used in the real world and where improvements may be needed through:

• Bridging Studies ​
• Competitive Benchmarking 
• Formative Usability Studies
• Human Factors Validation Testing 
• Labelling Comprehension Studies 
• Summative Studies 

With more than 20 years of experience and thousands of product types evaluated, our expertise spans all levels of complexity, product types and systems including: 

• Class I, II, and III Medical Devices
• Collection and Diagnostic Kits
• Combination Products 
• Emergency Use Products 
• Kits and Container Closure Systems
• Laboratory Instrumentation 
• Software as Medical Devices