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  • 1.  Recommendation on MDSAP Auditing Organization

    This message was posted by a user wishing to remain anonymous
    Posted 17-Oct-2022 10:55
    This message was posted by a user wishing to remain anonymous

    Does anyone have a MDSAP auditing organization they would recommend to others? We are having lots of difficulty with our AO being responsive. Are others having a similar experience? We are wondering if we transition to another AO if we will still have difficulty due to staffing issues. Thanks in advance for any insight.


  • 2.  RE: Recommendation on MDSAP Auditing Organization

    Posted 18-Oct-2022 02:17
    Hello,

    I am not going to comment on this (ok I did), you are not alone and the "grass is not greener" on the other side.  If you are dis-satisfied with the service, going to another Auditing Organisation (AO) is probably not going to be your solution because many others have the same issues, if not worse.  If more companies file formal complaints to the Accreditation Body (the entity/regulatory body which certifies the AOs) something might actually change.  In addition, since Health Canada is the only regulatory agency which really requires MDSAP, file a formal complaint with them also (if you sell in Canada).  Contact your local/regional medical device industry body to get them involved.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Recommendation on MDSAP Auditing Organization

    Posted 21-Oct-2022 09:35
    I think it's hard for anyone to recommend an AO since every company has different experiences. We went from an AO that had completely unrealistic expectations when they came in to audit us and their communication was awful. We switched to another organization and their response time is better but they still wait until the last minute to provide communications on audit dates, audit plan, or even provide communications for having to delay the audit.

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    Stacey Benser
    Senior Quality/Regulatory Manager
    York PA
    United States
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    Original Message


  • 4.  RE: Recommendation on MDSAP Auditing Organization

    Posted 21-Oct-2022 12:49
    I agree with Richard. There were two events recently that created vacuums and movement for NB and their work. MDR and the amount of effort required to approve devices under MDR requiring talent that takes years of graduate-level university classes, and COVID-19. 

    Finding a better org and them accepting you into their review is going to be another undertaking.

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

    Original Message


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