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Usability Testing of Medical Devices
by Usability Testing of Medical Devices
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Description
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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Product Details
- CRC Press Brand
- Feb 4, 2016 Pub Date:
- 1466595884 ISBN-10:
- 9781466595880 ISBN-13:
- English Language
- 0.93 in * 6.14 in * 9.21 in Dimensions:
- 2 lb Weight:
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