SPEAKER PROFILE



Ms. Christine Reilley

Business Development Director, Healthcare,; American Society of Mechanical Engineers

United States

The Role of Verification and Validation of Models and Simulations in Regulatory Submissions

Abstract

Medical device companies and regulatory agencies alike have recognized in recent years the benefits—and potential pitfalls—of the use of modeling and simulation in product development and regulatory approval. This talk will discuss how ASME V&V 40-2018 -- Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices provides modelers in the medical device industry with a framework for establishing model credibility requirements. More broadly, this presentation will address the current regulatory pathway for computer models in medical device submissions and the role that standards can play in supporting computer modeling for regulatory decision-making.

Bio

Christine Reilley is business development director of Healthcare for the American Society of Mechanical Engineers (ASME), based in New York City. As director, she leads the ASME Alliance of Advanced Biomedical Engineering (AABME), which focuses on creating and growing the Society’s portfolio of programs, products, and services in this area.

Christine had previously served as program manager in the ASME Emerging Technologies unit, developing content and conferences in areas focusing on bioengineering, nanotechnology, thermofluids, and materials. Previously, she spent more than 10 years in ASME Codes and Standards Publishing as an editor, overseeing the production of codes.

She earned an MS in Biomedical Engineering with a concentration in Tissue Engineering and Biomaterials from New Jersey Institute of Technology (NJIT). She received a BA in Journalism and Mass Media with a minor in Biological Sciences from Rutgers University, Douglass College.