Usability Testing of Medical Devices

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Usability Testing of Medical Devices achterzijde
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  • Usability Testing of Medical Devices achterkant

Since publication of the first edition, the FDA and other organizations and agencies have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this second edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates include guidance pertaining to new FDA and IEC requirements, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests.

Specificaties
ISBN/EAN 9781466595880
Auteur Michael E. Wiklund P.E.
Uitgever Van Ditmar Boekenimport B.V.
Taal Engels
Uitvoering Gebonden in harde band
Pagina's 480
Lengte
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