FDA Quality System Regulation for Medical Devices

Apr 24th, 2012Apr 25th, 2012
London, H9
GB
http://www.management-forum.co.uk/medical/eventid/1953
Phone:44 1483 730071
This course provides a comprehensive, thorough, and detailed introduction to the FDA's Quality System Regulation (QSR) for Medical Devices.
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Images of a 39-year-old who underwent screening mammography. Right craniocaudal (left) and mediolateral oblique (middle) views from preoperative mammography show suspicious grouped fine pleomorphic calcifications (arrows). After biopsy showed ductal carcinoma of situ (DCIS), patient underwent breast-conserving surgery, yielding final diagnosis of ductal carcinoma in situ (intermediate grade, hormone receptor positive). (Right) Screenshot of an output of a commercial AI tool applied to preoperative mammography. AI detected right breast lesion with score of 95% on both views (concentric colored circles). Present study’s reviewing radiologist deemed AI marking to correspond with site of DCIS.
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