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ASME V&V40 Industry Day 2018 -- Industry and FDA Slides for Public Distribution
Version 3 2018-06-18, 14:25
Version 2 2018-06-11, 19:21
Version 1 2018-05-30, 15:06
presentation
posted on 2018-06-18, 14:25 authored by Tina MorrisonTina Morrison, Luann Pendy, Anita Bestelmeyer, Melanie Vincent, Scott Taylor, Leonardo Angelone, Finn Donaldson, Jeff Bischoff, Ryan Ortega, Marc HornerThe 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 was a key topic at the 2018 V&V Symposium. Developed through close collaboration between device developers, regulatory agencies, and other device industry stakeholders, the ASME V&V 40 standard provides modelers in the medical device industry with a framework for establishing model credibility requirements. The anticipated publication date is July 2018.
The ASME V&V 40 Subcommittee leadership
coordinated an “Industry Day” event focused 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 have
garnered 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 (ODE) and the Office of Science and
Engineering Laboratories (OSEL), along with members of the ASME V&V 40
Subcommittee.
Attached is the slide deck with the presentations from our industry and FDA representatives.
