Safe products and satisfied users – this the definition of usability. Medical devices must be designed and manufactured in such a way that risks associated with ergonomic features are excluded or minimized.
Usability is the goal of ergonomics and includes the effectiveness, efficiency, learnability and user satisfaction with respect to a certain product. Usability engineering is described in standards EN 60601-1 and EN 62366. The aim is to design and manufacture a device so as to avoid safety-relevant user errors. Application of the standards also results in user-friendly products and thus satisfied customers.
Usability engineering identifies, evaluates and reduces risks that are caused by lack of user-friendliness and lead to user errors. It consists of process analysis, risk analysis as well as specification, verification and validation of usability. Usability engineering is documented in the usability file.
The usability of a medical device is an important safety factor and is thus included in the clinical evaluation.
We support you in all phases of usability engineering - in close cooperation with you and according to your needs.
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