Warning Letter: Failure to perform device software validation (ucm543694)

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Ofni Systems

Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g).  For example, you do not have records to demonstrate that your Imaging Software used with the Tio-H Digital X-Ray Sensor has been validated.  You do not have records to demonstrate that your firm has conducted a risk analysis to identify potential hazards and control measures with the Tio-H Digital X-Ray Sensor System.

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