WE KNOW HFE STRATEGY

We combine our thought leadership in Human Factors Engineering with years of experience in the trenches to develop HFE strategies that 1) satisfy regulators, ​ 2) are not overly burdensome, and ​3) give you confidence that your product is safe and effective. ​

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We work hard to set you up for success the first time. ​

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Tell us how we can help you with your:  ​

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

Our team of seasoned professionals take great pride in designing, executing, and reporting upon human factors tests that provide robust results AND tell a story. Our reports give any reviewer a front row seat to exactly what happened, what went well, what was of concern. By the final validation test, feel assured that all known use issues have been mitigated as best possible. And WE DO IT ALL FOR YOU from start to finish, including those difficult recruits. ​

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Tell us how we can help you with your:  ​

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

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Human factors for medical products has been THE FOCUS since our inception over 20 years ago. Over that time, we've worked on thousands of different medical products. These experiences allow us to apply a holistic approach to all our programs. We leverage findings from other products to mitigate any surprises as early as possible. Our HF expertise spans all levels of complexity from a single product for use in the home to multi-faceted systems used by teams of healthcare professionals. ​

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Tell us how we can help you with your:  ​

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