Usability Engineering and Human Factors

“First, do no harm” is an old medical mantra, mitigating the consequences of harm is at the core of our work on human factors. 

If you are developing a medical device, the development and the evaluation of its usability is mandated by the Food and Drug Administration (FDA) in the US, and by the Medical Device Directive (MDD) in Europe and the UK.

We follow a procedure set out in IEC 62366 to conduct our user research, assess risk areas, and carry out formative and summative evaluations to assist with your regulatory approval.