A Study on the Practical Application of ASME V&V 40 Standard for Computational Modeling and Simulation (CM&S) in Medical Devices

The increasing use of computational modeling and simulation (CM&S) in the medical device sector has heightened the need for ensuring simulation credibility. The ASME V&V 40 standard offers a structured framework for assessing credibility, consisting of 23 factors divided into three main categories: Verification, Validation, and Applicability. However, practical guidance for implementing these factors is still scarce. This study systematically reviewed and analyzed ten CM&S-related publications in the medical device field that utilized the ASME V&V 40 framework. It examined how each publication addressed the credibility factors and compared their implementation methods, evaluation criteria, and credibility levels. From this comparative analysis, we developed implementation strategies focused on credibility factors, field-specific characteristics, and model risk levels in real-world regulatory and development contexts. Key considerations for the practical application of each factor were identified, and recommendations for effective implementation were proposed. These findings offer practical guidance for ensuring credibility in CM&S-based medical device development, performance evaluation, and regulatory processes. By clearly demonstrating the applicability of the ASME V&V 40 framework, this work provides valuable direction for related industries and research institutions, aiming to improve CM&S credibility and promote its broader adoption in healthcare.