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Human Factors & User Research Specialists
A Human Factors and User Research Consultancy specialising in Medical Device, Diagnostics, FemTech, Digital Health and Combination Product Development
OUR SERVICES
Implement a Human Factors & Human Centred Design approach tailored to your development process
Discover innovation opportunities and better understand your users and their unmet needs
Design instructional materials, digital user interfaces and physical prototypes to test with your users
Assess your prototypes and production equivalent solutions with intended users; from formative to summative testing
Support comprehensive use-related risk analyses; evidencing compliance and instilling trust in your product
Facilitate sessions with your team; supporting Human Centred Design thinking, and developing skills
Strategy & Planning
Implement a Human Factors and Human Centred Design approach tailored to your development process
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Exploratory Research
Discover innovation opportunities and better understand your users and their unmet needs
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Instructional Materials Design
Design and develop effective instructional materials including Instructions for Use (IFU) and Quick Reference Guides (QRGs) for your users
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Usability Testing
Assess your prototypes and production equivalent solutions with intended users; from formative to summative testing
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Use Related Risk Management
Support comprehensive use-related risk analyses; evidencing compliance and instilling trust in your product
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HF Regulatory Documentation
Meet regulatory expectations with expertise for USA, UK and EU including IEC 62366, FDA HF Guidance and MHRA HF Guidance.
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We are Human was founded to ensure human needs are at the heart of design
OUR EXPERIENCE
We work with customers globally; from small start-ups to large international organisations, across Medical Devices, Diagnostics, FemTech, Digital Health and Combination Products