Regulatory Open Forum

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  • 1.  eIFU Services

    Posted 09-Jul-2020 23:14
    Hi!  If anyone has used/is using an eIFU service, I'm very curious as to the cost and experience.

    Thanks!

    Tina

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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  • 2.  RE: eIFU Services

    Posted 10-Jul-2020 03:00
    Hi Tina
    We are using Qarad (https://www.online-ifu.com/, e-mail: info@qarad.com) since some years, and are quite happy with them. Presently we have 372 IFU's uploaded, which costs us € 4'500 for 3 months, i.e. approx. €18'000 per year. But note the high number of IFU's we have uploaded (becaus of language requirements in Europe).
    Kind regards Oscar

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    Oscar Banz
    Head of QM & RA
    Grenchen
    Switzerland
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  • 3.  RE: eIFU Services

    Posted 10-Jul-2020 03:23
    Hello,

    I have also been experienced with Qarad in the past and they are knowledgeable in eIFU deployment.  The other experience I have is you can actually create this yourself with some IT support on your own website.  We found it was not too difficult, but as you can imagine the more IFUs you have, the complicated and challenging will be to maintain.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 4.  RE: eIFU Services

    Posted 10-Jul-2020 19:56
    Dear Tina,
    We use Qarad BV for our elabeling they have different rates of billing depending on how many documents.  We would like more customization in the service, but have not had customer complaints about availability of labeling.  For around 40 documents they charge 1550 euros.

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    Constance Bridges RAC, MBA
    SVP, Quality and Regulatory
    Marana AZ
    United States
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  • 5.  RE: eIFU Services

    Posted 11-Jul-2020 05:34
    Hi Tina,

    I have some experience with dokspot.
    https://dokspot.io/
    I'm not sure about the costs, but you can run a free trial with full access to dokspot.

    Best, Dirk

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    Dirk Steinhoff PhD
    Senior Consultant
    Zug
    Switzerland
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  • 6.  RE: eIFU Services

    Posted 11-Jul-2020 21:09
    Thanks everyone!  We're currently outsourcing IT, so this info is very helpful to evaluate our options

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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  • 7.  RE: eIFU Services

    Posted 12-Jul-2020 04:16
    Does anyone know if 207/2012 will be updated shortly to be in line with MDR and allow a broader set of devices?

    Thanks,

    Karen J.

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    Karen Jaffe, MS MBA RAC
    Director, RA
    Obalon Therapeutics
    Carlsbad CA
    USA
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  • 8.  RE: eIFU Services

    Posted 12-Jul-2020 20:33
    That is an excellent question!  It would really help if it were expanded to anything but home use devices, which is consistent with a lot of other countries.

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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