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Usability Testing of Medical Devices|Michael E. Wiklund P. E.

Usability Testing of Medical Devices

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Overview

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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Details

  • ISBN-13: 9781466595880
  • ISBN-10: 1466595884
  • Publisher: CRC Press
  • Publish Date: February 2016
  • Dimensions: 9.3 x 6.1 x 1.1 inches
  • Shipping Weight: 2.1 pounds
  • Page Count: 480

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