Medical Device Human Factors

Regulatory Bodies and Human Factors

Are you wrestling with Human Factors Regulations? How are you accommodating Human Factors guidance in your product design and management processes? Do you need help with the MDR? What about Brexit and the UKCA? HirLan partners with medical device manufacturers to assist with Human Factors Engineering through product innovation, development, validation/evaluation testing, and delivery.

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Customized Support

We can be your in-house Human Factors practice in whole or in part helping you meet ANSI/AAMI HE75:2009(R)2013, IEC 62366-1:2015, MDR (CE Mark) and FDA Human Factors Requirements. No need to worry about how to, or what is evaluation (formative) or validation (summative) Human Factors testing. HirLan can provide application & product design, application prototype, focus group, and user testing.

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Human Factors Testing

HirLan can help you incorporate the right evaluation and validation methods at each step of your product lifecycle to ensure you meet all regulatory requirements, e.g., FDA 510(k) Human Factors, MDR and CE Mark Regulations. We provide application & product design, application prototype, and user testing in compliance with ANSI/AAMI HE75:2009(R)2013 and IEC 62366-1:2015 meeting all CE Mark and FDA 510(k) Human Factors Requirements. This includes both evaluation (formative) and validation (summative) Human Factors testing.

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