Warning Letter: Faliure of validation process (ucm170224)

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Ofni Systems

Your company did not ensure that its design verification and validation process detected design discrepancies with [redacted] the [redacted] printed circuit board (PCB) of the MTS trial stimulators using the [redacted] components that later caused loss of stimulation, and therefore, failure to complete trial implants.

View the original warning letter.


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