Template For IB For A Medical Device

Regulation & Governance

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    Dear all

    not sure where to post this but I am running out of ideas where to ask.  Does anyone know whether an IB for a Medical Device is similar to an IB for an IMP?  If not similar does anyone have a template that you may be happy to share; we are involved with a new trial which has a Class III Medical Device and it falls under the scope of the MD Directive.

    I have a number of colleagues/friends in industry but no-one is willing to share as it is too confidential.  Im only after a Template; a real example would be nice too, but i do appreciate that a real IB will be confidential.

    Many thanks for your help

    Joanna Black

     

    Joanna Black
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