Regulatory Advisor of Computational Modeling
Center for Devices and Radiological Health, Food and Drug Administration
Dr. Morrison is the Regulatory Advisor of Computational Modeling for the Office of Device Evaluation. She leads the Regulatory Review of Computational Modeling Task Force at CDRH, which has developed guidance documents on the use of modeling and simulation in the regulatory evaluation of medical devices. She dedicates much of her energy towards advancing regulatory science through modeling and simulation because she believes the future of medical device design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization.
Dr. Morrison is a mechanical engineer who studied Cardiovascular Biomechanics as a post-doctoral fellow at Stanford University. During that time, she investigated the in vivo biomechanics of the aorta using gated CT imaging; those data are now used as boundary condition inputs for computational modeling and bench-testing of endovascular devices. She also serves as co-chair of the ASME V&V40 Subcommittee on Computational Modeling of Medical Devices, where she is helping to lead the development of a strategy to assess the credibility of computational models. She is working with a team at CDRH to implement this strategy into the review of premarket submissions that leverage computational modeling. Since 2008, she has been a scientific reviewer on a variety of medical device premarket submissions in Cardiovascular Devices. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.