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December 5, 2016
Zyno Medical LLCProduct: infusion pumps Date:12/5/2016 Failure to establish and maintain procedures to control product that does not conform to specified requirements, and to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example: Your firm did not open a non-conforming report (NCR) on 7/30/15, when...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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