Join ANSYS for a regulatory overview exclusive for Intuitive Surgical.
The medical device industry has traditionally relied on bench testing, animal testing, and clinical trials to guide the development and assessment of medical devices. Regulatory agencies have established their approval processes around these three sources of evidence as a result. In the mid to late 2000’s, it became clear that the medical device industry was increasing their reliance on computational modeling to develop new products. But a lack of clear and concise guidance regarding model validation requirements limited the utilization of this new source of evidence. The FDA responded by establishing computer modeling as a regulatory priority in 2011. One outcome of their efforts is the development of a regulatory pathway for computational model results in device submissions. This presentation will provide background and overview of this new pathway.
Marc Horner, Ph.D.
Vice Chair V&V 40, Principal Engineer, Healthcare, ANSYS, Inc.
Dr. Marc Horner is a principal engineer leading technical initiatives for the healthcare industry at ANSYS, Inc. Marc Joined ANSYS after earning his Ph.D. in Chemical Engineering from Northwester University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory, science, and clinical applications. These include Vice Chair of the ASME V&V 40 Sub-Committee and Chair of the AAPS Process Modeling and Simulation Focus Group (PMSFG). Lastly, Marc is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.
Lunch will be provided. We look forward to seeing you at the event!