NDLI: The Use, Misuse, and Abuse of Design Controls

Content Provider	IEEE Xplore Digital Library
Author	Samaras, G.
Copyright Year	1983
Abstract	FDA-mandated design controls for medical devices provide a structured, systematic engineering paradigm that supports human-centered systems engineering. Engineering design controls are nothing more than the fundamental elements of classical systems engineering. The human focus is enabled through the iterative reidentification of stakeholders, reassessment of their NWDs, and reconciliation of their evolving/conflicting NWDs. The implementation of design controls and embedded risk management must begin prior to commercial development to reap the full benefit of the approach; partial approaches dilute or negate the effectiveness and efficiency of this nearly century-old systems engineering paradigm. Properly employing engineering design controls is a strategic business decision. The central value of this proposition is the reduction of economic, technical, and operational risks for both producers and consumers; regulatory compliance is a secondary benefit. Misuse or abuse of design controls only undermines long-term profitability and increases the risks to the consumer.
Page Count	7
File Size	1750954
Starting Page	12
Ending Page	18
File Format	PDF
ISSN	07395175
Volume Number	29
Issue Number	3
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2010-05-01
Publisher Place	U.S.A.
Access Restriction	Subscribed
Rights Holder	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Subject Keyword	Design engineering Medical control systems Reliability engineering Biomedical engineering Biological control systems Control systems Safety devices Product development Engineering in medicine and biology Systems engineering and theory
Content Type	Text
Resource Type	Article
Subject	Biomedical Engineering

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