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Usability Testing of Medical Devices

Usability Testing of Medical Devices

Allison Y. Strochlic / Jonathan Kendler / Michael E. Wiklund P.E.

304,62 €
IVA incluido
Disponible
Editorial:
Taylor & Francis Ltd
Año de edición:
2015
Materia
Medicina preclínica: ciencias básicas
ISBN:
9781466595880
304,62 €
IVA incluido
Disponible

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Sobre IBD

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.

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