Industry uses computational modeling to identify worst-case configurations thereby reducing the amount of physical testing. At the same time, stakeholders and regulators need to have confidence that computational models are credible. The ASME V&V 40 Standard – Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices – provides a framework for establishing the credibility requirements of a computational model for a context of use (COU) based on model risk. Establishing credibility requirements before executing simulation bounds the scope of the simulation, physical testing, and documentation for a particular project.

This webinar provided an overview of the V&V 40 standard with a specific example. Although the framework is applied to a medical device, it is applicable to other industries.

About the Presenter

Linda Knudesen, Senior Principal Mechanical Engineer, Syncroness, Inc.

As senior principal mechanical engineer at Syncroness, Inc., an Alten Group company, Linda Knudsen leads FEA and CFD simulations of medical devices, aerospace systems, and industrial equipment to support design decisions under a quality management system certified to ISO 13485, ISO 9001, and AS9100. Since 2015, Linda has been a member of ASME V&V 40 Verification and Validation in Computational Modeling of Medical Devices and contributed to the development of the V&V 40 standard. In 2020, Linda became a member of the NAFEMS Americas Steering Committee. She has presented at ASME V&V symposiums as well as NAFEMS CAASE conferences.

She is committed to advancing the effective implementation of simulation by deploying standardized training and procedures, integrating V&V into the simulation process, and collaborating with the international engineering analysis community to extract best practices.

Linda has an M.S. in Manufacturing Systems Engineering from Stanford University and a B.S. in Mechanical Engineering from Rutgers University. She was a Fulbright Scholar to the Swiss Federal Institute of Technology and has lived and worked in France, Switzerland, and Germany. She is fluent in French and German.