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Usability Testing of Medical Devices
ISBN-13:
9781466595897
Veröffentl:
2015
Seiten:
477
Autor:
Michael E. Wiklund P. E.
eBook Typ:
PDF
eBook Format:
EPUB
Kopierschutz:
2 - DRM Adobe
Sprache:
Englisch
Beschreibung:
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.
Introduction. Risk management and usability testing. The commercial imperative. Testing costs. Anatomy of a usability test. Types of tests. Writing a test plan. Choosing a participant sample and recruiting participants. Test environments. Adding realism. Selecting tasks. Conducting the test. Interacting with participants. Documenting the test. Analyzing test data. Reporting results. Validation testing.
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