scope:

The scope of the Standard encompasses physics-based computational models used for medical device applications. This Standard augments other standards that present V&V methodologies, such as ASME V&V 10 and ASME V&V 20. Therefore, this Standard is intended for the practitioner who is familiar with V&V terminology. It does not present a method for incorporating user expertise or modeler pedigree, nor does it describe the specific V&V activities and rigor that are needed to establish credibility for a particular application and/or device. Instead, this Standard presents a framework for the practitioner to make that assessment using sound engineering judgment. This Standard is not a step-by-step guide, nor is it intended to present a quantitative method for establishing model credibility. While the framework was developed specifically for medical devices, the V&V 40 Subcommittee considers this Standard to be general enough to be applied to other disciplines.

Purpose

The purpose of this Standard is to provide a framework for assessing the relevance and adequacy of completed V&V activities that establish credibility of a computational model. The credibility should be commensurate with the degree to which the computational model is relied on as evidence of device performance, functional characteristic, and/or safety to support a decision, and the consequences of that decision being incorrect. This Standard will help users communicate the value of the completed V&V activities and establish the associated credibility of the computational model to support a decision.