Regulatory Open Forum

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  • 1.  accessories modification

    This message was posted by a user wishing to remain anonymous
    Posted 8 days ago
    This message was posted by a user wishing to remain anonymous

    Hi forum members,

    If we are modifying 3rd party accessories to include adaptors/fibres to connect with our device, will this modification result in us (device manufacturer) to become the manufacturer of the accessory? And that all responsibilities of manufacturer including technical documentation and DHF will be assumed by the device manufacturer?



  • 2.  RE: accessories modification

    Posted 7 days ago

    Yes, that's correct, you would became ethe legal manufacturers with all responsibilities.



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



  • 3.  RE: accessories modification

    This message was posted by a user wishing to remain anonymous
    Posted 7 days ago
    This message was posted by a user wishing to remain anonymous

    Yes.

    Sometimes it's easier to work with the original manufacturer, asking them to produce a compatible version.

    Or sell a separate adaptor device that does nothing but make the connection.