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 careful consideration of your device complexity, user groups, and trends with reviews/approvals, our team develops regulator-ready HFE strategies that integrate seamlessly with your medical device development cycles from early planning to final validation 

We combine our experience in Human Factors Engineering and Human Factors Strategies to satisfy regulations and provide confidence in the safety and effectiveness of your device through:

• Expert Reviews 
• FDA Meeting Planning
• Gap Analyses 
• Human Factors SOPs ​
• Human Factors Regulatory Strategy
• Human Factors Studies of all types

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 

Turn human factors into a regulatory advantage.