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  • 1.  EN ISO 14971 Training for annex ZA

    Posted 29-Jan-2015 11:04
    Hello

    Does anyone know of an in depth Risk Management training course offered in the US for EN ISO 14971?  We need it to be specific to annex ZA. 
    I have seen one specific to electrical devices, but ours are not electrical, and I have seen several that are for the non-EN version.  We manufacture mostly class IIa and some class I dental devices, such as adhesives and composites. 
    It seems strange to me that I can't find one.  I'm hoping maybe someone can point me in the right direction. 

    Thanks

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    Carrie Osing
    Regulatory Affairs Manager
    Bisco, Inc.
    Schaumburg IL
    United States
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  • 2.  RE: EN ISO 14971 Training for annex ZA

    Posted 29-Jan-2015 11:21


    FDA News offers a detailed in-depth two-day training course on risk management that covers EN ISO 14971:2012. The course covers ISO 14971:2007 as the basis, and includes the issues raised by the EU, particularly Annex ZA. There is also a section on how the update an existing Risk Management File to address the issues. The course covers additional applications of risk management including the ISO guidance document and the relationship to other standards including Usability Engineering.

     

    The brochure isn't up on the FDANews website yet, but the planned dates are July 14 & 15 in Boston, MA and November 10 & 11 in Oak Brook IL.

     

    I teach the course.

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: EN ISO 14971 Training for annex ZA

    Posted 29-Jan-2015 11:29
    In case you are looking for

    an online seminar (LIVE), please visit at http://globalcomplianceseminar.com/event/live-seminar-risk-management-medical-devices-ivds-systematic-holistic-approaches/

    For a recording at http://wp.me/P2EoXX-1nl


    Original Message