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  • 1.  Training on ISO 13485, 21 CFR part 820 and MDR requirements

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    Dear all,

    in your annual training plan do you schedule training on ISO 13485, 21 CFR part 820 and MDR requirements every year for the team for continual educational scope? Is this a requirement or expectation from Notified Body or FDA?

    thanks



  • 2.  RE: Training on ISO 13485, 21 CFR part 820 and MDR requirements

    Posted 11 days ago

    Hi,

    My own experiences is that NB or FDA often request evidences of qualification but no frequency is specifically defined.



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    Quang Tran
    VP QARA
    Antony
    France
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  • 3.  RE: Training on ISO 13485, 21 CFR part 820 and MDR requirements

    Posted 11 days ago

    Hello Anon,

    There is no requirement for an annual "refresher", though in my experience we usually did a refresher - documented group training - with all employees a few weeks before our ISO certification surveillance or re-cert audit.  We also did include 21 CFR 820, GMP, Good Documentation Practices (GDocP), and record management.  Everyone gets in their day-to-day work, so we usually did the annual review.  We tried not to make it boring or dull, we did try to make it interesting and relevant at that point in time - such as talking about issues we might be having, new things, new products, etc., with always reflecting back on the regulatory requirements.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
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  • 4.  RE: Training on ISO 13485, 21 CFR part 820 and MDR requirements

    Posted 11 days ago

    I would take this a bit further, there is NO requirement for training (or certification) on ISO 13485, 820 or MDR. The requirement from both is to determine the necessary competence and then establish that the necessary competence has been achieved/maintained. This could be done by the day-to-day work and your experience. If you are training or teaching others, why do you need to go to a training?? Stop using 'training' (like 'read & understand') and make sure the requirement for competence is met.



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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    St. Cloud State University
    Becker MN
    United States
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  • 5.  RE: Training on ISO 13485, 21 CFR part 820 and MDR requirements

    This message was posted by a user wishing to remain anonymous
    Posted 11 days ago
    This message was posted by a user wishing to remain anonymous

    No, we don't. New folks in the Quality team may get sent for training, but generally everyone in Quality and Regulatory is expected to know those regulations and standards, and many others, working with them daily. The rest of the organization gets trained on our quality system SOPs - the way we implement the regulations.




  • 6.  RE: Training on ISO 13485, 21 CFR part 820 and MDR requirements

    Posted 3 days ago

    However, the FDA require an annual awareness training of the importance making safe medical devices.  That might include parts of 820



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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
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