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Does IEC-62304 suggest that the tools used for configuration management be validated(CSV'd))

Discussion in 'IEC 62304 - Medical Device Software' started by ConstantChange22, Oct 12, 2022.

  1. ConstantChange22

    ConstantChange22 New Member

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    I am trying to understand if IEC 62304 only suggest that configuration management process should exist and be followed or does it also enforce that the tools used for documentation (Sharepoint, Confluence etc) and software code repository (Github, Jenkin) be validated (CSV'd) as well ?
     
  2. yodon

    yodon Well-Known Member

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    Absolutely! It's addressed from planning throughout and there's a whole section in the standard dedicated to it. Curious why you would think otherwise?

    62304 itself doesn't but normally, you'd be operating under a regulation (e.g., 21 CFR 820 / MDR) or standard (e.g., 13485) that does. That said, I would like to suggest you take a look at the recent FDA guidance on Computer Software Assurance. This brings much needed sanity into the CSV discussion.
     
    ConstantChange22 likes this.