Regulatory Open Forum

 View Only

  • 1.  Recommendation for third-party ISO 13485 certification body?

    Posted 11-Jan-2022 14:55

    Hi all,
     I'm looking for recommendations for ISO 13485 auditors. My client is in central Illinois.


    Thanks so much!
    Aimee



    ------------------------------
    Aimee Feuser
    Trestlework, LLC
    Chicago, IL
    ------------------------------


  • 2.  RE: Recommendation for third-party ISO 13485 certification body?

    Posted 12-Jan-2022 04:11
    Hello Aimee,

    Generally I comment to these type of questions with three criteria:
    1. Is the ISO 13485 certification body accredited? And follow on what type of certification body is needed, e.g. if selling in Canada will need a MDSAP AO?
    2. Cost including travel expenses if auditors have to come from somewhere else.
    3. How is the certification body responsiveness?  This can also include technical capability and resource availability, i.e. giving you a 4 month lead time for audits, can translate into waiting a while for the actual certificate.

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

    Original Message


  • 3.  RE: Recommendation for third-party ISO 13485 certification body?

    Posted 12-Jan-2022 11:37
    If you're looking for a CB, I've heard good things about Dekra (haven't used) and I've enjoyed working with BSi.

    I was with TUV during the whole EU breast implant scandal where they were the NB, and they seriously overshot and became way too conservative with all of their clients - so I cannot recommend them. Maybe they are better today.

    ------------------------------
    Joshua Lust
    ------------------------------

    Original Message


  • 4.  RE: Recommendation for third-party ISO 13485 certification body?

    Posted 13-Jan-2022 03:23
    Hi Aimee,

    I agree with the points for consideration Richard mentions. Esp. in considering whether your organization may need MDSAP.
    I have a positive experience with DEKRA, but in EU.

    Kind regards,
    Korina

    ------------------------------
    Korina Anagnostou
    Leiden
    Netherlands
    ------------------------------

    Original Message


Related Content