Innovations or added capacity of a medical device or medical device system to provide conditions for users to use the device safely, effectively and efficiently, especially if operated in conjunction or simultaneously with another medical device or technology, however, must fulfil defined ergonomics, usability and human factors engineering principles.
Parameters to identify suitable options to improve medical device usability, performance and safety require careful thought, including, for example, software enhancements not for safety purposes, security patches or simply to improve operating efficiency. Inadequately-defined usability can lead to use-errors or un-ergonomic products. For these reasons-among others-medical device design must include requirements on ergonomic features, use environment, physical properties and characteristics along with user interfaces, displays plus delivery on information essential for a user to be able to use the device such that it can achieve performances intended under conditions of use specified by the manufacturer.
QFI has 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. For instance, we compile usability engineering documents to fulfil expectations of IEC 62366 series standards. Where required, we construct and co-ordinate usability surveys, studies and questionnaires for our clients.
QFI‘s services 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.