WHAT WE DO EVERYDAY

Is to spend our time immersed in human factors and usability engineering activities like performing usability testing around the world, collaborating in human factors risk assessments, documenting user requirements or submitting documents to ethics committees. Our work is completely focused around compliance, and our ISO 13485 certified Quality Management System is the basis of all of this user-focused effort. We continuously improve and are passionate in what we do.

This is why we are the human factors partner of choice for many global organisations.

Please explore our services to find the service you require information on. If you cannot find what you require, please contact us.

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HUMAN FACTORS ENGINEERING

This involves applying human factors tools and methodologies prior to or early stage development of a medical device, software or system to:

  • Identify innovation opportunities
  • De-risk use errors
  • Increase user experience and desirability
  • To aid with CE marking
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HUMAN FACTORS TESTING

Formative & Summative testing of medical and pharmaceutical devices, software and systems to comply with the following regulations:

  • FDA – United States of America
  • MHRA – United Kingdom
  • IEC 62366-1 & EU MDR (2017/45/EC) – Europe