Woo Young Medical, 1/13

Woo Young Medical, 1/13

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Warning Letter citing failure to validate software that provide graphical representation of flow rates.

Description

Woo Young Medical, 1/13

This Warning Letter includes an observation regarding the lack of evidence that validation was completed for the software used to provide the customer with the graphic representation of the flow rate of the device. The company did not have user requirements, input, or output requirements for the software.

pa document category Warning Letter
Regulation Category Devices – GMP
FDA Office CDRH
System Category Design
Citation Category Validation

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