Regulatory Open Forum

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  • 1.  Consultant Referral

    Posted 09-Dec-2016 11:35

    I am looking for a referral for a consultant who has experience with blood collection devices to help an Indian company submit a 510(k).  Specific experience with these devices is required.

     

    Please reply directly to my e-mail with your contact information and I will supply to the potential client.

     

    Thank you

    Lee Leichter

    President

    P/L Biomedical

    10882 Stonington Avenue

    Fort Myers, FL 33913 USA

    O: +1-239-244-1448

    F: +1-815-550-0162

    C: +1-239-994-6488

    E: leichter@plbiomedical.com

     

     



  • 2.  RE: Consultant Referral

    Posted 10-Dec-2016 13:15

    Hi Lee

    I have worked with Arterial Blood Gas collection devices in the past.  I would love to hear more about the product to see if it is a good fit.  You can learn more about my business philosophy at lean RAQA systems

    lean RAQA systems remove preview
    lean RAQA systems
    With any new venture, risk and unknowns are inherent. In the medical product market, regulatory is a key element in a successful business strategy. Lean RAQA Systems supports the due diligence process with strategic regulatory assessments reducing unknowns by exposing possible challenges that will impede product commercialization or require costly remediation efforts.
    View this on lean RAQA systems >

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    Michelle Lott RAC
    Principal
    Lean RAQA Systems
    520-275-9838