Human factors in the design of medical devices - Approaches to meeting international standards in the European Union and USA

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• 作者：Mary Beth Privitera^a ; ^{privitmb@uc.edu} ; Mark Evans^b ; ^{M.A.Evans@lboro.ac.uk} ; Darren Southee^b ; ^{D.J.Southee@lboro.ac.uk}
• 关键词：Medical device ; User-centered design ; Regulatory requirements
• 刊名：Applied Ergonomics
• 出版年：2017
• 出版时间：March 2017
• 年：2017
• 卷：59
• 期：part_PA
• 页码：251-263
• 全文大小：2161 K
• 卷排序：59

文摘

Case studies of design process for 18 device developers were analyzed and 4 challenges identified. Developers lack direct access to users for the purpose of device development. Contract formalities prohibit free exchange of device design and evaluation. Users lack understanding of their input impact within the MDD process. User attitudes can negatively impact the application of human factors processes.