USABILITY AND HUMAN FACTORS ENGINEERING – MEDICAL DEVICES
QFI has a long experience of assisting medical device manufacturers in the field of usability and human factors engineering. Our specialists can produce full usability engineering documentation to fulfil leading international standards such as the IEC 62366 series. Where required, we construct and co-ordinate usability surveys, studies and questionnaires for our clients.
Medical device design must include requirements on ergonomic features, the use environment, physical properties and characteristics, along with user interfaces, displays plus delivery of information essential for a user to be able to use the device so that it performs as intended under the conditions of use specified by the manufacturer.
QFI can help in this area from earliest design phases to post-market initiatives. Where necessary, we can define usability criteria to include in post-market studies, too.
