Warning Letter: Newer Software not validated (ucm340300)

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Ofni Systems

Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example: Your firm’s design validation procedures outlined in Section 4.6 of the Design Control Procedure, Doc. No. [redacted] do not ensure that the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation are documented in the Design History File (DHF). Thirty test records from a clinical study conducted as part of the design validation for the AnyView A8 Monitor were reviewed. The results of the design validation, including the identification of the design, the unit tested, the date, and the individuals performing the validation were not documented. In addition, the investigator noted that a software revision had since occurred; however, your firm admitted that the newer software version had not undergone software validation.

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