ASME V&V 40 Industry Day

Cost

FREE

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 will be a focus area of discussion during the 2018 ASME V&V 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 both the Office of Device Evaluation and the Office of Science and Engineering Laboratories, along with members of the ASME V&V 40 Subcommittee.

• When: Tuesday, May 15, 2018
• Where: Hyatt Regency, Minneapolis, MN
• Who should attend: Medical device modelers & 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.

Questions should be directed to Tina Morrison, Chair of the V&V40 Subcommittee: tina.morrison@fda.hhs.gov or Ryan Crane, ASME V&V40 Secretary CraneR@asme.org

Register Here