Day

November 25, 1998
Ultramedic Ltd. 11/25/98 Infusion Pump Analyzers 6. Failure to have an established protocol to validate computer software for its intended use when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, there is no validation protocol for the validation study...
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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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