ASME V&V 40
Assessing Credibility of Computational Models through Verification and Validation: Application to Medical Devices Workshop
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 course will provide an overview of the standard and highlight its key tenets through a few medical device examples and active discussions.
This workshop is being held in conjunction with the VPH 2022 Virtual Physiological Human Conference.
Pre-event reading materials
Obtain and familiarize yourself with the V&V 40 Assessing Credibility of Computational Modeling and Simulation Results through Verification and Validation Standard prior to the Workshop, a copy of the V&V 40 standard does not come with your registration.Purchase Document Online
Instructors are the officers of the ASME VVUQ Subcommittee 40:
Dr. Jeff Bischoff
ZIMMER BIOMET; VVUQ SC 40 Chair
Dr. Jeffrey Bischoff is the Director of Biomechanics at Zimmer Biomet, where he has been since 2006. Prior to joining the medical device industry, he completed his Ph.D. in Mechanical Engineering at the University of Michigan, served as Assistant Professor at the University of South Carolina. Over the past ten years, Jeff has supported device development efforts using computational analysis across a wide range of orthopaedic applications, and throughout the total product life cycle from design ideation through regulatory clearance and commercialization. He has been actively involved with the ASME V&V40 Sub-Committee, including as chair of the orthopaedic working group and as vice-chair of the sub-committee. He recently was appointed to chair of the sub-committee, effective 2019-2022.
Dr. Marc Horner
ANSYS; VVUQ SC 40 Vice‐Chair
Dr. Marc Horner is a Distinguished Engineer leading technical initiatives for the healthcare industry at Ansys. Marc joined Ansys after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME V&V-40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Lastly, Marc is an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine.
Dr. Payman Afshari
Depuy Synthes; VVUQ SC 40 Vice‐Chair
Dr. Payman Afshari is a Sr. principal engineer at the DePuy Synthes, Johnson and Johnson. He has more than 15 years of experience in applying computaitonal modeling asimulaiton (M&S) to address challenging problems in design and manufacturig of spinal implans. For the past 10 years, he has been involved in promoing the use of M&S across product life cycle including regualtory evidence generation. Currently, he is vice-chair of ASME V&V40 subcommttee, an active member of ASTM, the Avicenna Alliance, A European predictive medicine organizaiton, Medical Device Innovation Consortium (MDIC) and InSilcioUK initiative. He has co-authored several publicaiton in the area of verification, validation and uncertainty quantification of models in medical device development and regualtory applicaitons.
BSc. Angel Luis Guzman Rodriguez
ASME; VVUQ SC 40 Secretary
S&C Project Engineer Advisor graduated from Hofstra University in 2004 with a Bachelor of Science degree in Industrial Engineering. Started working at ASME shortly after graduating. Responsible for the ASME VVUQ Subcommittee 40 on Verification, Validation, and Uncertainty Quantification in Computational Modeling of Medical Devices as well as many other committees.