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Looking for a human factors and usability engineering consultancy to support your medical device development, usability testing, or regulatory submission?
Whether you are planning a formative usability study, preparing for a human factors (HF) validation test, or developing a use-related risk analysis (URRA), we’d be happy to discuss your project and explore how we can support your team.
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Why Choose Human Factors Insight?
- Specialized Medical Device Expertise. We focus exclusively on human factors and usability engineering for medical devices, helping manufacturers develop products that can be used safely and effectively by their intended users.
- 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, ISO 14971 and other international regulatory expectations.
- End-to-end services. From early-stage user research and formative usability evaluations to human factors validation testing and regulatory submission support, we help medical device manufacturers navigate every stage of the product development lifecycle.
- Accesible consulting. We work with startups, SMEs, and global medical device manufacturers, providing pragmatic solutions tailored to each project’s stage of development and regulatory objectives.