Enabling Compliance of Medical Device Computational Models per the ASME V&V40 Standard through SPDM

The medical device industry has traditionally relied on bench testing, animal testing, and clinical trials as the primary sources of evidence for establishing the safety and effectiveness of medical devices with regulators. A growing dependence on computational modeling and simulation (CM&S) during product development eventually led to the need for frameworks establishing the credibility of models based on this new source of evidence. The ASME V&V40 standard on “Verification and Validation in Computational Modeling of Medical Devices” is a central element of this transition. This standard provides a risk-based framework for establishing the credibility requirements of a computational model by guiding users in establishing & assessing the verification, validation, and uncertainty quantification requirements for a computational modeling activity. However, implementing and then documenting the various credibility requirements and associated credibility activities can be time-consuming and lack traceability, consistency, and security within the organization. To address these needs, our team developed a template-based, end-to-end credibility workflow in Ansys Minerva. This template is a simulation process and data management solution which guides users through the ASME V&V 40 standard procedure in a stepwise fashion. The template tracks all aspects of model development: from identifying credibility requirements to defining simulation work requests to communicating with internal stakeholders. Thus, this end-to-end solution establishes and manages the digital thread for computational modeling data throughout product development which not only benefits the simulation engineers using modeling as part of product development, but also quality and regulatory affairs professionals responsible for managing and reviewing regulatory submission data. The solution therefore represents a readily adopted standard operating procedure that can be deployed throughout the medical device industry and any other industry using modeling and simulation for critical decisions.