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  • 1.  ISO 14971:2019 Published

    Posted 10-Dec-2019 11:51
    Find it in the ISO store here.

    What do you think about this revision? Do you have plans for transition? 

    This is a much looked for update to help meet requirements for EU MDR/IVDR. Does it affect your plans for updating your post-market surveillance?

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States
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  • 2.  RE: ISO 14971:2019 Published

    Posted 10-Dec-2019 22:30
    EN ISO 14971:2019 is also slated for publication on December 18th. Along with the ISO version you can find these documents at your standards supplier at the release date.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


  • 3.  RE: ISO 14971:2019 Published

    Posted 11-Dec-2019 01:48
    That's good news! What about TR 24971? Any news there as well?

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    Britta Cyron
    Bochum
    Germany
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    Original Message


  • 4.  RE: ISO 14971:2019 Published

    Posted 11-Dec-2019 07:50
    ISO TR 24971:2019 submitted to ISO for publication.  However, ISO website shows it still "under development" with no publication date. Hopefully it will be before year end. This document will be extremely helpful in proving guidance for implementation of the updated risk management standard.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


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