Webinar
Using In Silico Evidence to Accelerate the Regulatory Approval of Cardiovascular Devices
The medical device industry has traditionally relied on bench testing, animal testing, and clinical trials as the primary sources of evidence for establishing the safety and effectiveness of medical devices with regulators. Increased reliance on computational modeling and simulation (CM&S) during product development has led to the need to establish regulatory frameworks that support the inclusion of this new source of evidence in submissions. The ASME V&V40 standard on “Verification and Validation in Computational Modeling of Medical Devices” is a central element of the FDA framework. This standard provides a risk-based framework for establishing the credibility requirements of a computational model by guiding users in establishing & assessing the verification, validation, and uncertainty quantification requirements for a context of use.
This webinar will review the ASME V&V 40 standard along with complementary FDA guidance that outlines a clear and consistent pathway for using CM&S in submissions. Progress in the global acceptance of CM&S evidence will also be reviewed.