Warning Letter: Failure to establish and maintain procedures for validation (ucm436707)

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Ofni Systems

“Your software development / validation does not include written procedures, structural and regression testing, and code reviews.

  1. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,

a. Your software development /validation:

    1. does not include written procedures covering the development/validation of the software used in your devices
    2. documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
    3.  software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.

….

c. The available clinical studies documentation for the following Evolution Oxygen Conservers:

      1. did not include the written protocol or the patient’s baseline saturation levels for the 900M model; and
      2. did not include the baseline saturation levels or the device settings for the patients.”

View the original warning letter.


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