This Standard provides 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. It also augments other standards that present V&V methodologies, such as ASME V&V 10 and ASME V&V 20. Therefore, it 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. It 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.
- ANSI Approved
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- 1 file , 3.9 MB