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  • 1.  Recommendations for 3rd party Internal Auditor for EU MDR Technical Review

    Posted 06-Dec-2021 14:16
    Hi all!

    I expect to undergo the EU MDR audit in mid-2022 by our NB.

    Before we undergo that audit, I want to do a 3rd party internal audit for our Technical Documentation. Has anyone undergone an internal audit for MDR TD? Would you recommend your auditor?

    Thanks!

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    Kimberly Chan
    Lansdale PA
    United States
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  • 2.  RE: Recommendations for 3rd party Internal Auditor for EU MDR Technical Review

    Posted 06-Dec-2021 14:40
    We have. I am hesitant to advert for them here so I will PM

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 3.  RE: Recommendations for 3rd party Internal Auditor for EU MDR Technical Review

    Posted 06-Dec-2021 15:17
    I used Oriel Stat A Matrix and was happy with the results.

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    Charnelle Thomas RAC
    Director, Regulatory Affairs
    Canton GA
    United States
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    Original Message


  • 4.  RE: Recommendations for 3rd party Internal Auditor for EU MDR Technical Review

    Posted 07-Dec-2021 08:39
    Thanks to you both!

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    Kimberly Chan
    Lansdale PA
    United States
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    Original Message


  • 5.  RE: Recommendations for 3rd party Internal Auditor for EU MDR Technical Review

    Posted 07-Dec-2021 08:45
    RQM+ has provided this service to a number of clients.  Feel free to reach out.
    www.rqmplus.com

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    John Haney, MSLBE, CBA
    Operations Manager & Sr. Principal Advisor
    RQM+
    https://www.rqmplus.com/
    ------------------------------

    Original Message


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