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Looking for human factors and usability engineering support for your medical device? Whether you are preparing for an FDA submission, EU MDR compliance, or the next stage of product development, Human Factors Insight can help you develop a medical device that is safe, intuitive, and regulatory-compliant.
Have a project in mind or simply want to discuss your usability strategy? Get in touch to schedule a non-obligatory consultation or request a quote.
Why Choose Human Factors Insight?
- Specialized Medical Device Expertise. We focus exclusively on human factors and usability engineering for medical devices.
- Global regulatory experience. All our services are aligned with United States FDA’s final guidance on human factors and usability engineering, Europe MDR, IEC 62366-1, and ISO 14971.
- End-to-end services. We help medical device companies at every stage of product development ranging from early formative usability testing through to human factors validation testing.
- Accesible consulting. We provide accessible and cost-effective human factors and usability consulting services to medical device startups, global medical device manufacturers, and pharemacuetical companies.