Usability Testing of Medical Devices - 2nd Edition

CRC Press

Usability Testing of Medical DevicesAuthor(s): Michael E. Wiklund P.E., Jonathan Kendler, Allison Y. Strochlic\nFormat: Hardback\nPublisher: Taylor & Francis Inc, United States\nImprint: CRC Press Inc\nISBN-13: 9781466595880, 978-1466595880\nSynopsis\nUsability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.\n\nSince 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 readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements .