Regulatory Open Forum

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  • 1.  Recommendation for ISO 13485 Internal Auditor Training course

    Posted 11 days ago

    I would like to obtain ISO 13485 Certified Internal Auditor training and welcome any training course recommendations. The course must be Exemplar certified, live virtual, or in-person in Maryland.

    I am leaning towards the 3-day virtual course offered by AQL (instructor is DEKRA). BSI also offers a 3-day virtual course but at a ~ 50% higher cost. TUV SUD offers a 2-day virtual course which I am leaning against given the other vendors feel 3 days is needed to cover the material.

    Thank you in advance for any recommendations.



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    Mark Mortellaro, Ph.D., RAC-Devices, RCC-MDR
    Sr. Principal Regulatory Scientist
    Maryland, USA
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  • 2.  RE: Recommendation for ISO 13485 Internal Auditor Training course

    Posted 10 days ago

    Hello Mark

    I would agree that a 3 day course is the best option and would personally also lead towards an IRCA approved course. I also would avoid BSI.

    Hope this helps.

    Emma 



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    Emma Nye
    Swiss Precision Diagnostics
    Milton Keynes
    United Kingdom
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  • 3.  RE: Recommendation for ISO 13485 Internal Auditor Training course

    Posted 9 days ago

    Hi everyone,

    I think a viable training, well to be considered might be the ISO 13485 Training Course Ireland - IRCA Certified (complyguru.com)

    In my humble opinion, best report for quality/accreditation/price report.



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    Marian Nicuriuc
    Sr. Regulatory Affairs Specialist
    Envista - ENTERPRISE
    Jüchen
    Germany
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  • 4.  RE: Recommendation for ISO 13485 Internal Auditor Training course

    Posted 10 days ago

    I took Management Systems Auditing and Leading Management Systems Audit Teams courses through Bsi.  These are TPECS courses.  I would just suggest that wherever you chose, it is TPECS so that you obtain a certificate of certification and not a certificate of completion.  It will serve you better in the future.  The Bsi course is 2-day requirement course, test, 1-day internal auditor course, and test.  I took the 1 additional day for the lead auditor competency.  I was very pleased with the training that I received from Bsi.

     

    Best of luck!

     

    D. Michelle Williams, CESCO

    VP – Operations

     

    Action Products, Inc.

    www.actionproducts.com

    301.797.1414 X1022

     

    https://www.linkedin.com/in/dmwilliamsvpopapiwvu88

     

     

    Action-MMD-Ribbon_Logo_5in_cmyk

     






  • 5.  RE: Recommendation for ISO 13485 Internal Auditor Training course

    Posted 10 days ago

    Check out Axeon.

    They are much less expensive, are Exemplar certified and it is a a longer # of days for the course. They are based out of Utah. They offer online and in-person courses. If you are a repeat customer,  typically you can get discounts. I have used them to get certified to

    Lead Auditor for QMS- FDA QSR/ISO 13485:2016, MDSAP Audit Approach  to ISO 13585:2016, and the EU MDR.

    I have also taken an official multi-day training course (well done) on ISO 14971:2019, and that was after having been on a lot of risk mgmt teams at 3M (using the old ISO 14971:2007).



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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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