Regulatory Open Forum

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  • 1.  RA Consultant for Software in/as Medical Device

    This message was posted by a user wishing to remain anonymous
    Posted 9 days ago
    This message was posted by a user wishing to remain anonymous

    Greetings!

    My small/mid-sized organization is interested in developing a software application for spatial tracking of a device (likely product code OLO). As we have never developed such a thing in-house, we'd like to engage with a consulting firm in this space who could provide guidance on product development and regulatory submission (US only). If anyone has any recommendations for a consultant or guidance on pathway, please feel free to drop your email here and I'd be glad to reach out. 

    Thank you!



  • 2.  RE: RA Consultant for Software in/as Medical Device

    Posted 9 days ago

    Hi Anon,

    VCLS and their Digital health group can assist you with regulatory development for a software MD in the US

    Kind regards,

    Clara



    ------------------------------
    Clara Desvignes
    Associate Director
    Voisins Consulting Life Science (France)
    Saint Grégoire
    France
    ------------------------------

    Original Message


  • 3.  RE: RA Consultant for Software in/as Medical Device

    Posted 9 days ago

    Hi Anon. I can help with you with this. I provide regulatory expertise for device manufacturers, including many software developers. 
    Pls visit my site for more. ...  medtechresults dot com.   Or reach me directly at  kevinm@medtechresults.com 

    I look forward to hearing from you. 
    Kevin McLellan



    ------------------------------
    Kevin McLellan
    Owner
    Memphis TN
    United States
    ------------------------------

    Original Message


  • 4.  RE: RA Consultant for Software in/as Medical Device

    Posted 9 days ago

    Hello Anon, 

    StarFish Medical's Regulatory team can help you with this task. We have an internal Software Engineering team that has experience with this sort of thing, so we understand it from a regulatory perspective. Feel free to reach out through our website, or reach out to me and I can put you in touch with our Business Development team. 

    Cheers,

    Sean



    ------------------------------
    Sean Mitchell
    StarFish Medical
    semitchell@starfishmedical.com
    ------------------------------

    Original Message


  • 5.  RE: RA Consultant for Software in/as Medical Device

    Posted 5 days ago

    certainly, you can contact me. 



    ------------------------------
    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
    ------------------------------

    Original Message


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