Four-hour training session on the V&V40-18 standard, ‘Assessing Credibility of Computational Models through Verification and Validation: Application to Medical Devices’
Friday, Sept. 6th, afternoon
Building on the success of training sessions at past VPH meetings, key members of the ASME VVUQ40 subcommittee will offer a four-hour training session on the V&V40-18 standard, ‘Assessing Credibility of Computational Models through Verification and Validation: Application to Medical Devices’. 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.
The training session will be facilitated by Jeffrey Bischoff (Zimmer Biomet; chair, VVUQ40), Payman Afshari (Depuy Synthes; co-vice chair, VVUQ40), Shiny Martis (Voison Consulting Life Science; member, VVUQ40), Walter Ocampo (Straumann; member, VVUQ40), and Brent Craven (US Food & Drug Administration; member, VVUQ40). The course will provide an introduction to key concepts of the standard including question of interest, context of use, model risk, and credibility. These concepts will be illustrated through the use of several specific medical device examples, providing the opportunity for spirited interaction between course faculty and registrants. Further, current activities within the ASME VVUQ40 subcommittee will be summarized, in recognition of gaps in the standard that have been realized since its release in 2018.
All registrants are encouraged to access and read the standard in advance of the training session.
