Design Control Requirements for Medical Device Development

Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. The article will focus on 1 of 14 elements of the Quality System Regulation (QSR)—Design Controls. A high-level overview of these design control requirement...

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Bibliographic Details
Published in:World journal for pediatric & congenital heart surgery 2012-01, Vol.3 (1), p.77-81
Main Author: Kinsel, David
Format: Article
Language:English
Citations: Items that cite this one
Online Access:Get full text
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