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September 24, 2013
By: Michael Barbella
References 1. Quality System Regulation, 21 CFR 820.30 (b), 61 F.R. 52654, October 7, 1996. 2. Quality System Regulation, 21 CFR 820.30 (e), 61 F.R. 52654, October 7, 1996. 3. Understanding Barriers to Medical Device Quality. Food and Drug Administration (FDA), October 31, 2011.
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