Ionetics electrolyte analyzers (IVD)

Ionetics 1/29/96 electrolyte analyzers

1. Failure to ensure specification changes are subject to controls as stringent as those applied to the original specifications of the device [21 CFR 820.100(a)(2)]. For example, your firm failed to document and approve changes made to components and software for your electrolyte analyzers.

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Dates:  February 4-6, 2020

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Dates:  June 2-4, 2020

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