Applied Human Factors in Medical Device Design
暫譯: 醫療設備設計中的應用人因工程
Privitera, Mary Beth
- 出版商: Academic Press
- 出版日期: 2019-06-18
- 售價: $5,470
- 貴賓價: 9.5 折 $5,197
- 語言: 英文
- 頁數: 360
- 裝訂: Quality Paper - also called trade paper
- ISBN: 0128161639
- ISBN-13: 9780128161630
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商品描述
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation.
- Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU)
- Explains technology development and the application of human factors throughout the development process
- Covers FDA and MHRA regulations
- Includes case examples with each method
商品描述(中文翻譯)
《應用人因工程於醫療器材設計》描述了一個人因工程工具箱的內容,並深入介紹了實證和分析方法論。這本書首先概述了設計控制過程,整合了根據 AAMI TIR 59 指導的人因工程和實務經驗。接著,它解釋了每種方法,描述了每種方法的重要性、潛在影響、理想使用時機以及相關挑戰。書中還討論了其他障礙,例如使用者與設計團隊之間的溝通障礙。這本書是人因工程、設計、工程、行銷和法規領域專業人士的優秀參考資料。
- 專注於滿足機構要求,涉及人因工程在美國和歐盟 (EU) 醫療器材開發過程中的應用
- 解釋技術開發及人因工程在整個開發過程中的應用
- 涵蓋 FDA 和 MHRA 的法規
- 每種方法均包含案例範例