Regulatory Open Forum

 View Only
  • 1.  Consultant - FDA - Electrical Muscle Stimulators

    Posted 20-Jul-2018 10:00
    Hi All
    Can anyone recommend a consultant that has specific experience in 510k clearing Electrical Muscle Stimulator devices (EMS) devices.

    regards
    Mike

    ------------------------------
    Mike Kilkelly
    Quality Manager
    Galway
    Ireland
    ------------------------------


  • 2.  RE: Consultant - FDA - Electrical Muscle Stimulators

    Posted 16-Oct-2018 17:43
    Hi Mike, 

    If you have not found someone, I'm sure we can find you an expert within our network.  Please send me an email at ratinder.dhami@networkpartners.com.

    Kind Regards, 
    Ratinder

    ------------------------------
    Ratinder Dhami
    Senior Scientific Advisor
    Network Partners
    www.networkpartners.com
    ------------------------------



  • 3.  RE: Consultant - FDA - Electrical Muscle Stimulators

    Posted 17-Oct-2018 03:14
    Rob Packard of Medical Device Academy is a good resource for 510(k) consultants.  He has done Muscle Stimulators before.  

    Thx,

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------