The Use, Misuse, and Abuse of Design Controls Human-Centered Systems Engineering

被引:1
作者
Samaras, George M. [1 ,2 ,3 ]
机构
[1] Univ Maryland, Sch Med, Baltimore, MD 21201 USA
[2] George Washington Univ, Grad Sch Engn, Washington, DC 20052 USA
[3] US FDA, Ctr Devices & Radiol Hlth, Rockville, MD 20857 USA
来源
IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE | 2010年 / 29卷 / 03期
关键词
Design methodology; Performance evaluation; Engineering management;
D O I
10.1109/MEMB.2010.936551
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
Design controls, a relatively new name for a nearly century-old systems engineering paradigm, describe an engineering management process that serves both producers and consumers. In my engineering practice, I have observed the use, misuse, and abuse of design controls. Misuse and abuse are not economically advantageous to the producer and create risks for the consumer. Understanding what are design controls, how and when they are used, and why they add value may encourage proper use and mitigate risks for both producers and consumers. © 2006 IEEE.
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页码:12 / 18
页数:7
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