This webinar covers parts of the following standard and guidance: IEC 62366-1:2020 and the FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices. Research Collective is our guest presenter for this webinar on usability engineering and the human factors process. The webinar also explains how usability engineering fits within the overall context of a quality system and design controls.

The origins of human factors/usability engineering are presented as a story with an instructive example from the aviation industry. The differences between formative usability testing and summative usability testing are explained. Finally, the rationale for the minimum number of users for usability validation is explained.

The FDA officially recognizes device-specific and general consensus standards published by national and international standards bodies. Standards recognized by the FDA related to human factors and the application of Human Factors Engineering/Usability Engineering (HFE/UE) to medical devices can be found in a table published by the FDA in the link provided.

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Medical Device Academy also offers a Usability Procedure compliant with IEC 62366-1:2020. The procedure includes a template for conducting summative (validation) usability testing authored by Research Collective. We also updated our design plan template to include usability testing elements.

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