V&V

Verification and Validation Symposium

Hyatt Regency Minneapolis, Minneapolis, MN

Conference
May 16 - 18, 2018

 
 

V&V40 Day

 

Save the Date: May 15, 2018
ASME V&V 40 Industry Day

The ASME V&V Symposium is an annual meeting dedicated to the emerging field of verification, validation, and uncertainty quantification (VVUQ) of computer simulations. This event brings together engineers and scientists from all disciplines that use computational modeling and simulation to discuss and exchange ideas and best practices for model VVUQ. The 2018 Symposium will take place in Minneapolis, MN to further engage the medical device community. 

The upcoming publication of the new ASME Standard V&V 40 -- Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation: Application to Medical Devices is key topic at this year’s Symposium. Developed through close collaboration between device developers, regulatory agencies, and other device industry stakeholders, the V&V 40 standard provides modelers in the medical device industry with a framework for establishing model credibility requirements. The anticipated publication date is June 2018.

The V&V 40 Subcommittee leadership is coordinating an all-day event focusing on the current regulatory pathway for computer models in medical device submissions and the role the ASME V&V40 standard can play in supporting computer modeling for regulatory decision-making. As such, we are seeking participation from computer modelers and regulatory affairs personnel to engage with the FDA Center for Devices and Radiological Health staff from the Office of Device Evaluation and the Office of Science and Engineering Laboratories and with the ASME V&V 40 Subcommittee members.

When: Tuesday, May 15, 2018
Where: Hyatt Regency, Minneapolis
Who should attend: Medical device modelers and regulatory affairs personnel

Presentations by BD, Medtronic, Zimmer Biomet, and FDA are planned, along with a regulatory panel to discuss the opportunities and challenges for advancing the use of modeling in medical device submissions. We would like to include your perspective so please set aside this day to learn from your peers about the opportunity this new regulatory pathway presents to industry.

If you have questions about the event, you can reach out the following V&V40 members:

Register at Eventbrite.