XZeal Technologies, 2/15

XZeal Technologies, 2/15

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Warning Letter citation noting failure to validate purchased software and incorrect risk analysis of software.

Description

XZeal Technologies, 2/15

Warning Letter contains observations concerning (1) failure to validate purchased software embedded in a medical device, and (2) incorrect risk analysis of the software.

pa document category Warning Letter
Regulation Category Devices – GMP
Date Published 2015
FDA Office Florida District
System Category Medical Device
Citation Category Risk Analysis, Validation

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