Regulatory Open Forum

 View Only

  • 1.  Wheelchair Test Lab

    Posted 21-Aug-2017 09:23
    Hello all,

    I'm wondering if anyone has had a positive experience with a Wheelchair testing laboratory, for testing according to international standards to support a 510(k). The wheelchair is a mechanical wheelchair, product code IOR.  I have had trouble with the quality and sufficiency of report writing in the past and do not want to repeat that experience. Any suggestions?

    Thank you in advance!

    Diane Horwitz



    ------------------------------
    Diane Horwitz, Ph.D., RAC
    President
    Mandell Horwitz Consultants LLC
    Fairfax VA
    United States
    ------------------------------


  • 2.  RE: Wheelchair Test Lab

    Posted 23-Aug-2017 23:38
    ​Diane, you may try TUV.  Our experience with TUV Product Services GmbH in Hannover has been exceptionally positive but other TUV centres should offer equally good service.
    TÜV SÜD America Locations

    Homi


    ------------------------------
    Homi Dalal RAC
    Regulatory Affairs Leader
    Dynamic Controls
    Christchurch
    New Zealand
    ------------------------------

    Original Message


  • 3.  RE: Wheelchair Test Lab

    Posted 24-Aug-2017 08:59
    Thank you Homi!

    Do you have specific experience with TUV in terms of wheelchair testing, or general medical device testing?

    Best,
    Diane

    ------------------------------
    Diane Horwitz RAC
    President
    Mandell Horwitz Consultants LLC
    Fairfax VA
    United States
    ------------------------------

    Original Message


Related Content