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  • 1.  Clinical Evaluation Report

    Posted 28-Dec-2017 11:22
    Hello
    It is clear that literature clinical data related to a predicate device should be searched in compliance with the MEDDEV
    my question is related to the general clinical background search (about the disease, clinical data for similar devices that can NOT be predicate but can add  clinical background data)  should meet the requirements per the MedDev guidance  
    thank you

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    Nitza

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  • 2.  RE: Clinical Evaluation Report

    Posted 28-Dec-2017 11:30
    ​Nitza, I'm sure a number of people here would be happy to try to answer your question, but so far you haven't posted a question, just a couple of declarative sentences.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


  • 3.  RE: Clinical Evaluation Report

    Posted 28-Dec-2017 13:35
    Hi Nitza,

    I'm assuming you're asking if clinical background establishing state of the art should be conducted as stated in MEDDEV. Not necessarily. It is up to us to decide on the search strategy, databases, clinical guidelines to use but the MEDDEV (esp. Rev 4) gives us good direction and instead of reinventing the wheel, we could just follow it. We would end up looking at similar sources of data anyway. All that matters is you have a defined documented search strategy that includes scientifically valid data (RCTs, meta analyses etc). Coming up with a clinical evaluation plan and identifying different data sources & search methodology is a good way to go about it.

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    Vidyalakshmi Jayaraman
    RA specialist
    MA
    United States
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    Original Message


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