IEC 62366 & IEC 60601-1-6: standards for usability engineering
As most medical devices are also safety-relevant devices, they must comply with certain requirements in terms of usability. In addition to the usability factors of efficiency, effectiveness, and satisfaction of customer needs,, safety is to be considered also. IEC 62366 (as a universal standard) is the follow-up to IEC 60601-1-6, specifying the requirements for the analysis, specification, development, as well as the verification and validation of usability.
As many incidents with medical devices are linked to a lack of usability, international certification bodies and authorities increasingly direct their attention to compliance with the requirements. Our team knows all these requirements and supports you in developing the required usability file and in integrating it into your development process.
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