Guidance on applying human factors to medical devices
MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
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This guidance is primarily aimed at manufacturers of all device classes and developers of medical devices and drug-device combination products, and UK Approved Bodies responsible for assuring the quality of those devices.
It applies to the design of future products and changes in user interfaces of existing products, rather than those already on the market.
The guidance clarifies that usability engineering is an iterative process, involving design, testing and validation of design stages; it also requires attention to the post-market phase, since evidence may come to light while a device is being used in clinical practice that the design requires further improvement.
A usability engineering process can, and should, be applied by device manufacturers in the identification, assessment and mitigation of potential patient and user safety risks; also in the analysis of incidents that have occurred, in order to identify learning and put into place corrective actions to improve device design.
Last updated 12 February 2021 + show all updates
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Updated guidance to reflect the end of the transition period. The updates are primarily around this guidance applying to Great Britain, changes in references to legislation and the introduction of the new UKCA mark.
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First published.