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    shru04's Avatar
    shru04 Posts: 1, Reputation: 1
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    #1

    Sep 27, 2018, 05:00 AM
    Design and development procedure of medical device plant?
    Hello everyone,
    I am a manufacturer and want to start a new medical device manufacturing plant, but having poor knowledge of this field. So that's why I am looking for some expertise who help me with this.
    Curlyben's Avatar
    Curlyben Posts: 18,469, Reputation: 1857
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    #2

    Sep 27, 2018, 09:03 AM
    Hire a professional.
    ma0641's Avatar
    ma0641 Posts: 15,681, Reputation: 1012
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    #3

    Sep 27, 2018, 09:47 AM
    Well, you will need FDA approval before you do anything, months or maybe years of in field study with people who might use this device, $$$$$ of Product Liability insurance etc. Are you sure the medical field is where you want to go-
    "having poor knowledge of this field".

    Here is one case with a very experienced well known company-https://www.drugwatch.com/2014/05/06/medtronic-settles-infuse-bone-graft-lawsuits/

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