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  • 1.  SaMD Release Notes

    This message was posted by a user wishing to remain anonymous
    Posted 18-Jul-2022 09:22
    This message was posted by a user wishing to remain anonymous

    Hi,

    For a SaMD, are there any requirements around what types of issues should be made known to the users in release notes? Should all known issues be included in release notes? Or are there any thresholds / categories that are typically used to decide which issues to report on?

    Would it be ok to limit this to only user-facing issues (with workarounds or countermeasures)?


  • 2.  RE: SaMD Release Notes

    Posted 19-Jul-2022 04:06
    Dear Colleague,

    I do not know definite requirements. In case there are applicable standards for verification, those certainly should be applied for each versions of SaMD (eg. verifiying SaMD on PCs that analyses records of Holter monitors  accoring to IEC 60601/2-47:2012). For all the others I would develop and set up a verification system using standard input signals. 

    regards

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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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    Original Message


  • 3.  RE: SaMD Release Notes

    Posted 20-Jul-2022 09:26
    Dear Anon,

    clause 8.4 of IEC 82304-1 should be relevant for your question.

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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


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