Medicines Healthcare Products Regulatory Agency
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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.
To be read in conjunction with the guidelines on post-market surveillance.
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.