Usability Testing Experts FDA 510(k) Human Factors Guidance The Human Factors Promise - Safe, Effective, Usable Products

FDA 510(k)

Are you wrestling with the new FDA 510(k) Human Factors Regulations? How are you accommodating the FDA 510(k) Human Factors guidance in your product design and management processes? Do you need help with the CE Mark? HirLan partners with medical device manufacturers to assist with Human Factors Engineering through product innovation, development, validation/evaluation testing, and delivery.

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, CE Mark and FDA 510(k) 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.

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 FDA 510(k) Human Factors 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.