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  • 1.  CMDR checklist

    This message was posted by a user wishing to remain anonymous
    Posted 22-Apr-2022 07:51
    This message was posted by a user wishing to remain anonymous

    Hi All, 

    We're in the process of an MDSAP audit for Canada and our NB has asked us to provide our CMDR essential requirements checklist. Has anyone had experience with this? This isn't a request we have seen before, and we didn't receive a NC as the requirements are documented in our procedure. 

    I'm wondering if this is something others have experienced, and if there is a reliable source for the checklist?

    Thanks!


  • 2.  RE: CMDR checklist

    Posted 22-Apr-2022 14:28
    Edited by Kevin Randall 22-Apr-2022 14:35
    I have succeeded with my clients in achieving Canadian MDSAP (and before that, CMCDAS) conformity using either approach.  Like with the EU, Australia, UK, Switzerland, etc., there's no actual legislative requirement for a checklist or trace matrix; we simply need to prove conformity and give the necessary justifications.  My most recent MDSAP certifications didn't involve such a checklist but instead involved a less structured approach.  So, if one can devise an alternative way to do this using a method other than a checklist or trace matrix, then one is legislatively permitted to do so.

    But at the end of the day, it can be argued that the easiest, and certainly most sophisticated, way to do this is via a checklist.  Feel free to contact me offline for a Canadian Safety and Effectiveness Requirements checklist.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: CMDR checklist

    Posted 24-Apr-2022 14:46
    Edited by Stephanie Grassmann 24-Apr-2022 14:47
    Dear Anonymous

    They are requesting that you address Section 10 to 20 of the Canadian Medical Devices Regulations (SOR/98-282) titled Safety and Effectiveness Requirements. 
    https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-2.html#h-1021426
    There are different methods to address these regulatory requirements.
    For instance, copy the regulatory text into an excel sheet (first columns) and add columns to add answers or comments to each point. In a similar method in which some manufactures address Annex I of the EU MDD or MDR.  


    Best Regards,
    Stephanie






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    Stephanie Grassmann
    Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
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    Original Message


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