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  • 1.  Technical File for Stand Alone Software

    Posted 16-Dec-2016 15:26

    Can anybody provide suggestions as to the format of a Summary Technical Document (STED) for stand alone software (SAS) for a class IIb SAS in the EU?  Many sections of the standard IMDRF STED format for a physical device will be Not Applicable.  This would be our first submission for SAS to our NB.

    Thank you,

    Mitch

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    Mitchell Johnson
    Arden Hills MN
    United States
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  • 2.  RE: Technical File for Stand Alone Software

    Posted 16-Dec-2016 18:25
    Mitch,

    You may still use the said format (IMDRF/GHTF STED) and indicate what sections apply/don't apply with reasoning.

    As for software, please pay attention to all anomalies (identified and mitigated/controlled) with a holistic RM. 

    Please refer to IEC/EN 62304:2006 or 2015 and EN ISO 14971:2012

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    Original Message


  • 3.  RE: Technical File for Stand Alone Software

    Posted 17-Dec-2016 15:31

    Mitch,

    I just worked with a client whose standalone software was classified as Class I and the client self-certified for CE mark.  Be sure to consult MEDDEV 2.1.6.  We followed the list of requirements in Annex VII of MDD and developed our documentation.

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    Karen Bannick MA, RAC, FRAPS
    Principal & Founder
    Bannick Consulting LLC
    karen@bannickconsulting.com

    Original Message


  • 4.  RE: Technical File for Stand Alone Software

    Posted 20-Dec-2016 09:48

    Thank you Karen and David for your suggestions.  I like the self-certification idea!

    --MJ

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    Mitchell Johnson
    Arden Hills MN
    United States

    Original Message


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