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FDA Uses Digital Evidence to Accelerate Innovation - A "Straight from the Source" Webinar

01:32:00

Jul 10, 2019 10:30 AM

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Speakers

Tina M. Morrison, Ph.D
Deputy Director @U.S. FDA Division of Applied Mechanics, OSEL, CDRH
During her 11 years at the FDA, Tina has been working to advance the role of computer modeling and simulation in medical device design and product evaluation. She chairs the FDA Modeling and Simulation working group, and advises CDRH on simulation research and policy efforts. Additionally, Tina has led the development of pathways for enhancing modeling credibility and acceptance. For instance, she led the development a verification and validation standard for ASME, which culminated in 2018 with the first-ever set of evaluating procedures for computational modeling of medical devices, the ASME V&V 40 standard. Because of these efforts, Tina was selected as the 2019 Federal Engineer of the Year for FDA. She is the Deputy Director of the Division of Applied Mechanics in FDA’s Office of Science and Engineering Laboratories. She chairs the ASME Verification and Validation Committee, and is an Associate Editor for the Journal on Verification, Validation and Uncertainty Quantification.
Daniel R. Matlis
President @Axendia Inc.
Daniel R. Matlis is President of Axendia, an analyst firm providing trusted advice to Life-Science Executives on Business, Technology and Regulatory issues. Dan has almost three decades of industry experience spanning the Health-Science value chain. He has been an active member in FDA’s Case for Quality Initiative since 2014 and has presented Axendia’s research findings to industry executives and the FDA officials. Dan began his career at Johnson & Johnson, where he provided leadership in the areas of technology, regulatory compliance and business. Before founding Axendia, Dan was a Partner, VP and General Manager at a leading Life-Science consultancy firm. He is a frequent lecturer at Industry events and has published numerous research reports and articles on key issues facing the Life-Sciences and Healthcare industries. Dan holds a BS in Electrical Engineering from Polytechnic University (now NYU School of Engineering) in NY and a MS in Management from NJIT.