Regulatory Open Forum

 View Only
  • 1.  Imaging guide change

    This message was posted by a user wishing to remain anonymous
    Posted 29-Apr-2021 18:03
    This message was posted by a user wishing to remain anonymous

    Dear all,

    I have a concern and need you advise please. Do we need to submit a change on image area request to plan an implant manufacturing . Initially CT scan Full leg scan but now we will request additionally CT knee only .
    Do we need to submit this change. Also how tis king of change which is not link to the device but could affect the planning is manage by regulatory authorities please.

    Thank you.

    Rgds,