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Our Policy's

 
REGULATORY COMPLIANCE

Risk Management

All our work complies with International Standards and Guidance For Human Factors and Risk Management. We work with clients all over the Globe (UK, Europe, USA and the Emerging Markets) to build robust Usability Engineering Files for their products.

International:

  • IEC/BS EN 62366-1:2015 Medical devices — Part 1: Application of Usability Engineering to Medical Devices

  • IEC/BS EN 62366-2:2016 Medical devices — Part 2: Guidance on the application of Usability Engineering to Medical Devices

  • AAMI/ANSI HE-75:2009 Human Factors Engineering – Design of Medical Devices

United States:

  • ‘Applying Human Factors and Usability Engineering to Medical Devices’. FDA Guidance. February 3rd 2016

United Kingdom:

  • Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products, MHRA Draft Guidance June 2016