Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices
ASME V&V 40 — Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices, was published in 2018 to support the credible use of modeling and simulation within the medical device industry. This standard was developed through close collaboration between medical device developers, regulatory agencies, and other device industry stakeholders, and provides modelers in the medical device industry with a framework for establishing model credibility requirements.
This introductory workshop will provide an overview of the standard and highlight its key tenets through a few medical device examples and active breakout discussions.
The online V&V 40 Workshop will be held via Zoom on April 7, 2021 from 1:00-5:30 PM EDT.
Once you have registered for the event, details on how to connect to the Workshop via Zoom will be sent to you one day prior to the event.
1:00 PM: Welcome and ASME Standards Development Introduction
1:25 PM: Virtual walk-through of V&V40, Jeff Bischoff
1:45 PM: Introduction of Key Concepts – COU, Risk, Credibility, Payman Afshari
2:15 PM: Introduction of Key Concepts – Credibility Factors, Marc Horner
2:45 PM: Instructions for Breakout Rooms and Break
3:00 PM: Breakout Sessions (attend 1 of 3)
4:45 PM: Break and Return to Central Discussion Room
5:00 PM: FDA Perspective on ASME V&V40, Kenny Aycock
5:20 PM: Wrap-up, Jeff Bischoff
Pre-Event Reading Materials:
Obtain and familiarize yourself with the V&V 40 Standard prior to the Workshop. A copy of the V&V 40 standard does not come with your registration.
V&V40 Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices standard is available for purchase online at: www.asme.org/codes-standards
For more information, contact Kate Hyam, HyamK@asme.org.