Regulatory Open Forum

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  • 1.  Recommendations for US Agent?

    Posted 20-Oct-2016 16:50

    Can anyone recommend a company that offers US Agent services for medical device companies?

    This is for a very small company that currently plans to market only one device in the US.  It would prefer a smaller firm that specializes in this service, rather than a larger firm that offers it as one of a wide range of services.  Here are two examples:

    http://fdaagents.com

    http://www.usagentservices.com

    ------------------------------
    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
    ------------------------------


  • 2.  RE: Recommendations for US Agent?

    Posted 21-Oct-2016 02:01

    Hi Julie,

    we are working with Kevin Walls from www.reginsight.com

    Best,

    Dirk

    ------------------------------
    Dirk Steinhoff PHD
    Regulatory Affairs Manager
    Hocoma AG
    Volketswil
    Switzerland



  • 3.  RE: Recommendations for US Agent?

    Posted 21-Oct-2016 22:43

    Thanks, Dirk, but they really don't want a firm that offers a range of services.  They want a firm that specializes in US Agent services, like the two in the links.

    ------------------------------
    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



  • 4.  RE: Recommendations for US Agent?

    Posted 22-Oct-2016 12:09

    OK, let's try this again...

    If you work (or have worked) at a medical company located outside the US, and have used the services of a US Agent similar to the two companies linked below, and were satisfied with their service, I would be very grateful to get your referral.

    This is the type of company my client is looking for:

    http://fdaagents.com

    http://www.usagentservices.com

    ------------------------------
    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



  • 5.  RE: Recommendations for US Agent?

    Posted 22-Oct-2016 12:21
    Julie,

    You may also want to tell your client that what should be considered FIRST (what is important) before shopping around additional US agent services. 

    I've helped and interacted with many foreign firms. 

    As an analogy, they shop around first before thinking about what to buy and why.  Then later they may realize "we have to think about first what we need." 

    Action to Take: Please get your client understand what services are actually needed down to the bottom.

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567





  • 6.  RE: Recommendations for US Agent?

    Posted 23-Oct-2016 01:36

    David, what kind of additional US Agent services would you suggest they consider/

    ------------------------------
    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