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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 to establish the safety and efficacy of medical devices with regulators. Computational modeling was recently established as a fourth pillar of pre-market evaluation. The ASME V&V40 standard on “Verification and Validation in Computational Modeling of Medical Devices” has been critical to this transition. This standard provides a risk-based framework for establishing the credibility requirements of a computational modeling activity that ensures the model has sufficient credibility for a specific context of use. However, implementing the ASME V&V40 standard and then documenting the various credibility requirements and associated credibility activities is process intensive and time consuming. Organizations often face challenges with coordination between the various stakeholders involved in the process as well as a lack of consistency, security, and traceability of the computational modeling data and other evidence. To address these needs, Ansys developed an end-to-end credibility workflow that guides users through the ASME V&V40 standard procedure in a stepwise fashion on the Ansys Minerva simulation-process and data management (SPDM) solution. This involves defining a question of interest and context of use, performing a risk analysis, and evaluating each credibility factor as defined by the V&V 40 standard. Once the plan is established, the credibility activities associated with each factor can be requested and executed from within the system. Finally, the decision as to whether the model is sufficiently credibility as well as the various reports summarizing the credibility plan and credibility activities are documented. The template leverages Minerva’s core capabilities, such as data management, version control and metadata extraction; this ensures traceability of the end-to-end model development process. In addition, the template supports multiple personas, enabling a collaborative workflow, while ensuring each user has the appropriate access rights to access and modify the data all from a single system. In summary, this solution manages and establishes the digital thread for products that rely on computational modeling as part of product development. This benefits simulation engineers as well as quality and regulatory affairs personnel who manage and review regulatory submission data.

Document Details

ReferenceNWC23-0472-extendedabstract
AuthorsKarri. S Horner. M Ingle. R Jaura. A Shirke. M
LanguageEnglish
TypeExtended Abstract
Date 18th May 2023
OrganisationANSYS
RegionGlobal

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