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Writing Human Factors Plans & Reports

For Medical Technology Development


Summary: This book provides the foundation for developing specific human factors engineering (HFE) work products that are needed to meet the FDA's human factors engineering (HFE) guidance. The authors have created a fictitious company and product to generate concrete examples of the plans and reports developed during various stages of HFE. The book includes an HFE project plan, a formative usability test plan and report, a summative (i.e., validation) usability test plan and report, and an HFE report. These work products and additional content outline the activities necessary to develop safe and effective medical devices, making this book an ideal resource for anyone interested in the medical technology field.

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Product Code:
HFP
Author:
Michael Wiklund, Laura Birmingham, Stephanie Alpert Larsen
ISBN Number:
978-1-57020-689-4
Pages:
240
Standards Formats
Currently Selected: Print
AAMI Member:
$125.00
List Price:
$179.00
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