Physicist, Division of Imaging, Diagnostics & Software Reliability
OSEL, CDRH, FDA
• Introduction to modeling and simulation at CDRH
• Computational modeling in cardiovascular implant durability assessments: an FDA perspective
• Computational modeling in orthopedic regulatory submissions
• A mock submission to initiate a medical device clinical trial using modeling and simulation
• In silico imaging clinical trials for regulatory evaluation of mammography devices