Regulatory Open Forum

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  • 1.  eIFU Hosting Service Recommendations

    Posted 22-Oct-2019 09:58
    Hello Colleagues

    I am considering engaging the services of a third party eIFU hosting service and am wondering if you have any recommendations.  Obviously the service/website would need to be compliant with FDA, EU, and other geography requirements for eIFU.

    Thanks tons for your advice!  

    Best Regards,  Lauren

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    Lauren Kamer RAC
    Sr. Director of Regulatory and Clinical Affairs
    United States
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  • 2.  RE: eIFU Hosting Service Recommendations

    Posted 23-Oct-2019 02:48
    Lauren,

    I know there are a couple out there providing services, though the only one I have used directly is eifu.com and seems to work well - though it is still "being developed" and not sure how stable.  I am also familiar with Qarad and they have been doing eIFUs for many years now.  Depending on the number of eIFUs or version you have, it maybe might be easier to host it yourself also.  One advantage of hosting yourself is having complete control over what is up there and also providing access or limited access depending on the content or IFU.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: eIFU Hosting Service Recommendations

    Posted 28-Oct-2019 13:17
    Hi Richard

    Thank you for your advice!  I'm sorry for the delay in my reply.  

    Best Regards,  Lauren

    ------------------------------
    Lauren Kamer RAC
    Sr. Director of Regulatory and Clinical Affairs
    United States
    ------------------------------

    Original Message


  • 4.  RE: eIFU Hosting Service Recommendations

    Posted 23-Oct-2019 03:50
    ​Dear Lauren,

    We at Qarad offer these services in full compliance with the EU and US regulations.
    More information can be found on our website: https://www.qarad.com/e-labeling-eifu

    If you wish some additional information or a free demo please let me know and I will gladly set that up for you.

    Kind regards,

    Kirsten

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    Kirsten Van Garsse
    Regulatory Affairs Manager
    Geel
    Belgium
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    Original Message


  • 5.  RE: eIFU Hosting Service Recommendations

    Posted 28-Oct-2019 13:44
    Hello Kirsten

    Thank you!  I would be interested in receiving a demo and information.  Please contact me at lkamer@integrityimplants.com.

    Best Regards,  Lauren

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    Lauren Kamer RAC
    Sr. Director of Regulatory and Clinical Affairs
    United States
    ------------------------------

    Original Message


  • 6.  RE: eIFU Hosting Service Recommendations

    Posted 23-Oct-2019 11:08
    Hi Lauren,

    Several of our customers are using Vault PromoMats with Vault Digital Publishing to manage their eIFUs and other regulated digital assets.  Feel free to reach out and we'll be happy to share with you how we are helping device and diagnostic companies with EUMDR compliance requirements, including eIFU management.

    Warm regards,

    Terri

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    Terri Howard RAC
    Director, Strategy, Medical Device & Diagnostics
    Pleasanton CA
    United States
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    Original Message


  • 7.  RE: eIFU Hosting Service Recommendations

    Posted 28-Oct-2019 13:44
    Hello Terri

    Thank you!  I would be interested in receiving a demo and information.  Please contact me at lkamer@integrityimplants.com.

    Best Regards,  Lauren

    ------------------------------
    Lauren Kamer RAC
    Sr. Director of Regulatory and Clinical Affairs
    United States
    ------------------------------

    Original Message


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