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.
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
‘Applying Human Factors and Usability Engineering to Medical Devices’. FDA Guidance. February 3rd 2016
Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products, MHRA Draft Guidance June 2016