Warning Letter: Medical device company failed to validate computer software (ucm 355751)

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Ofni Systems

Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, your firm’s design verification procedure does not require that test equipment and software are fully validated, as needed, and prior to use in design verification activities.

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