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  • 1.  Post Market Surveillance - Servicing Medical Devices

    Posted 05-Oct-2018 08:54
    I am looking for training or specific information on the role and requirements for "servicing" medical devices.  Can someone suggest effective training or can point me in the right direction for articles or papers that would help educate me further in this area?  

    Thank You!

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    [Whitney] [Davis]
    [Quality Specialist III]
    [Instrument and Enterprise Services]
    [Thermofisher Scientific]
    [Marietta] [OH]
    [USA]
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  • 2.  RE: Post Market Surveillance - Servicing Medical Devices

    Posted 07-Oct-2018 07:17
    Hello,

    is the IEC 62353 Standard "Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment"
    related to your question? 
    .. Here is a link to the IEC preview: https://webstore.iec.ch/preview/info_iec62353%7Bed2.0%7Db.pdf.

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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


  • 3.  RE: Post Market Surveillance - Servicing Medical Devices

    Posted 09-Oct-2018 08:08
    ​I don't have any specific training recommendations with respect to Servicing, but the requirements are articulated in 21CFR.200.  Additionally, it might be helpful to read the preamble to the QSR regarding the Servicing section (subpart N) to get a better understanding of the FDA's thoughts in addition to industry feedback.  Finally, the FDA released a report last May on the topic.

    https://www.fda.gov/downloads/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDARA/UCM607469.pdf

    https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

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    Michael Winter RAC
    Curbell Medical
    Sr. Director, Quality and Regulatory Affairs
    Alden NY
    United States
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    Original Message


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