FDA CM&S Credibility Guidance for In Silico Medicine
Overview
Join us for this webinar to hear a comprehensive overview of the FDA's guidance on assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions, closely tied to ASME V&V40 standards. The session will cover the risk-informed credibility assessment framework - applicable to physics-based and mechanistic models - and explore its integration with Model-Based Design (MBD) principles.
Participants will be introduced to in silico medicine, a cutting-edge approach that leverages human physiology simulation models for device development. They will learn about the role of in silico models in enhancing medical device development and validation while ensuring compliance with FDA guidelines.
Highlights
- Overview of FDA CM&S guidance
- Framework for risk-informed credibility assessment
- Case studies and practical applications of in silico medicine and certification
About the Presenter
Akhilesh Mishra
Medical Devices Industry Manager | MathWorks
Akhilesh Mishra is the global medical devices industry manager at MathWorks. In his current role, Akhilesh closely works with customers developing digital health and medical devices, academic researchers, and regulatory authorities to help them see the value of modeling and simulation and how people can leverage the latest trends such as AI to build next-generation medical devices. Before MathWorks, he worked as a signal processing lead for NASA OIB mission focused on radar-based remote sensing of Greenland and Antarctica ice sheets to study global sea-level rise.
