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  • 1.  FDA HFE/IEC 62366 training

    Posted 11-May-2021 09:55
    Hello,

    Would anyone be able to recommend a training provider for human factors engineering training, in particular on summative evaluations?

    Thanks

    David

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    David Clafton
    Mirada Medical
    Oxford
    United Kingdom
    ------------------------------


  • 2.  RE: FDA HFE/IEC 62366 training

    This message was posted by a user wishing to remain anonymous
    Posted 11-May-2021 16:45
    This message was posted by a user wishing to remain anonymous

    I don't know that you can really separate summative studies -- it's all part of a complete package.

    Green Light Guru had a really good free one here: https://www.greenlight.guru/webinar/human-factors-fda along with a several podcasts

    Medical Device network had an OK one here: https://medicaldeviceevents.com/medical-device-conferences/human-factors-medical-device-user-risk/

    UL had a good one on finding use errors here: https://www.emergobyul.com/resources/intensive-look-methods-identifying-potential-use-errors

    Then based on all that, decide if you still need to pay for any training.



    Original Message


  • 3.  RE: FDA HFE/IEC 62366 training

    Posted 12-May-2021 03:44
    Thanks, I'll check them out.

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    David Clafton
    Mirada Medical
    Oxford
    United Kingdom
    ------------------------------

    Original Message


  • 4.  RE: FDA HFE/IEC 62366 training

    Posted 12-May-2021 08:13

    AAMI has several human factors courses developed to address FDA requirements as well as international requirements. 


    see Human Factors

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    Human Factors
    Is your device made with people in mind? Our human factors courses include FDA regulatory requirements as well as the process of applying human factors in the design of a medical device. For virtual training courses, please allow one week for US addresses and two weeks for international addresses for shipping of training materials and devices.
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    AAMI Main Page
    The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 professionals united by one important mission-the development, management, and use of safe and effective health technology.
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    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Edwin Bills Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


  • 5.  RE: FDA HFE/IEC 62366 training

    Posted 13-May-2021 04:04
    Thanks for the help. The AAMI one looks good for a full course and the greenlight guru one is a good intro/ refresher for our current process.

    ------------------------------
    David Clafton
    Mirada Medical
    Oxford
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: FDA HFE/IEC 62366 training

    Posted 13-May-2021 11:09
    That is a good summary, David.  There is an application for each.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Edwin Bills Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
    ------------------------------

    Original Message


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