Warning Letter: Failure to establish procedures (ucm268059)

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Ofni Systems

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures. You also have no documentation of design validation or design change controls for the Antalgic-Trak, including no documentation of risk analysis or structural [redacted] testing of the embedded software.

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