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Usability Testing of Medical Devices (Revised) (Hardcover) (Michael Wiklund)

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About this item

Citing their book as a good resource for those who have an interest, need, or direct role in conducting a usability test of a medical device (or system) or are presently studying the topic, Wiklund, Kendler, and Strochlic, with 50 combined years of usability testing experience, offer suggestions and recommendations. They answer the myriad questions that medical device manufacturers face when they test the usability of their devices in an orderly, readable manner. Aiming to write the kind of book they would have liked to have when they started testing medical devices, they provide the reader many illustrations and keep things simple. Seventeen chapters are: 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. There are illustrations, about the authors, how to use this book, the limitations of our advice, who could use this book?, references, and resources. Annotation ©2016 Ringgold, Inc., Portland, OR (protoview.com)

Since the publication of the first edition, the FDA and other regulatory groups 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 medical device manufacturers and other interested readers. Key updates include new requirements, detailed instructions for linking usability test tasks to risk analysis results, and methods for analyzing root causes of use errors that occur during usability tests. The book?s authors are well-known thought leaders in the medical device industry.

Edition: Revised
Number of Pages: 455
Genre: Medical, Technology
Sub-Genre: Industrial Health + Safety, Material Science, Biotechnology
Format: Hardcover
Publisher: Taylor & Francis
Author: Michael Wiklund
Language: English
Street Date: December 16, 2015
TCIN: 16560180
UPC: 9781466595880
Item Number (DPCI): 247-36-6984
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