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  • 1.  2020.12.28. EU MDR vigilance procedures - articles in the MED DEVICE Online

    Posted 28-Dec-2020 11:45

    Dear Colleagues,

    let me draw your attention to a few interesting articles in MED DEVICE Online:

    Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation

    Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management

    Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation

    regards



    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------


  • 2.  RE: 2020.12.28. EU MDR vigilance procedures - articles in the MED DEVICE Online

    Posted 28-Dec-2020 11:48

    Sorry, the 3rd one:

    https://www.meddeviceonline.com/doc/risk-based-postmarket-surveillance-pms-in-the-age-of-eu-mdr-a-systems-approach-0001

    still with regards



    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------



  • 3.  RE: 2020.12.28. EU MDR vigilance procedures - articles in the MED DEVICE Online

    Posted 31-Dec-2020 03:26
    Thanks for the links to the informative articles about PMS with respect to the MDR.  Very informative and reference to TIR 20416:2020 should be helpful to device manufacturers.  

    Kind regards,

    ------------------------------
    Alyssa Thomas RAC
    Principal Consultant
    Beaverton OR
    United States
    ------------------------------



  • 4.  RE: 2020.12.28. EU MDR vigilance procedures - articles in the MED DEVICE Online

    This message was posted by a user wishing to remain anonymous
    Posted 04-Jan-2021 09:10
    This message was posted by a user wishing to remain anonymous

    Thank you for posting this article. The website it is hosted on doesn't seem to use RSS feeds so I often miss good articles from this source.