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  • 1.  questionnaire ISO 14971 - Riskmanagement

    Posted 28-Oct-2013 05:47
    Dear All

    I am looking for a risk-analysis questionnaire:
    The questionnaire should consist the questions to cover the risks from the GHTF Guidance - Essential Principles of Safety and Performance of Medical Devices - November 2012.
    In addition I am looking for the same kind of questionnaire to cover the risks from  IEC 60601-1,- 1-6 (usability) -2-2 (HF), 2-18 (Endoscopy) in 2nd and 3rd Edition.

    It would be great if somebody could help with that documents because I am under high pressure of my Notified Body.


    Thanks in advance
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    Carsten Keller
    Director QM/RA
    Tuttlingen
    Germany
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  • 2.  RE:questionnaire ISO 14971 - Riskmanagement

    Posted 29-Oct-2013 07:50
    Carsten,

    The IECEE has blank Test Report Forms or TRF's for each of the IEC 60601 documents which could provide good input on the questionnaire your notified body is seeking.

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    Edwin Bills RAC
    Principal Consultant
    ELB Consulting
    Butler KY
    United States
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