New ASME V&V 40 Standard for Medical Devices Released

The American Society of Mechanical Engineering (ASME) Updates

The American Society of Mechanical Engineering (ASME) released the new Verification & Validation (V&V 40) standard for Computational Modeling of Medical Devices on November 15, 2018. This is big news for companies in the biomedical industry, particularly those using simulation to support the design and development of their medical devices.

The ASME V&V 40 standard isn’t intended as step-by-step guide. Instead, it aims to provide a framework for identifying and establishing the risk-informed credibility of a computational model.

“The ASME V&V 40 standard provides guidance on how to communicate your simulation verification and validation efforts within your own organization and also with a regulatory agency as part of your regulatory submission,” says Mark Goodin, SimuTech Group CFD Consulting Engineer and V&V 40 Subcommittee member. “Following this methodology, you use the simulation verification and validation results to help answer a specific question of interest. The goal is to determine the level of credibility needed with your simulation so that you can use the simulation results to support a decision that may influence the safety or health of a patient.”

Verification addresses whether your code is correctly solving the mathematical equations you’ve modeled and the accuracy with which you’ve solved those equations. Validation addresses how well the simulation results compare with what happens in the real world, such as in vitro or in vivo test data. In addition to model verification and validation, the ASME V&V 40 standard also discusses model applicability which considers the relevance of the validation activities to a specific context of use. The standard includes 13 credibility factors associated with the verification, validation, and model applicability activities, which are very helpful when establishing the credibility of your computational model.

Used in conjunction with the Food and Drug Administration’s guidance on “Reporting of Computational Modeling Studies in Medical Device Submissions,” the new ASME V&V40 standard will play a significant role in both establishing and demonstrating the level of rigor needed for computational modeling used in support of a regulatory submission. “It’s very exciting to be part of this journey and to help in clarifying the expectations and demonstrating the important role that computational modeling can play in advancing patient health,” says Goodin.

More on Computational Modeling Studies

Read more about the FDA’s current thinking in its document “Reporting of Computational Modeling Studies in Medical Device Submissions



  • 마샬 스미스
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    미국 최고의 스트레인 게이지 엔지니어링 컨설턴트

    스트레인 게이지는 압력이나 열팽창과 같은 비교적 일정한 하중으로 인한 정적 스트레인을 측정하는 데 사용할 수 있습니다.

    스트레인 게이지는 과도 현상이나 진동으로 인한 동적 스트레인을 측정하는 데에도 사용할 수 있습니다. 스트레인 게이지 측정의 정보는 유한 요소 분석(FEA) 모델의 검증에 유용하여 보다 정확한 작동 부하 및 고장 조사를 설정합니다.

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    Мерачите на деформација може да се користат и за мерење на динамичко напрегање поради минливи настани или вибрации. Информациите од мерењата на мерачот на деформација се корисни за валидација на моделите за анализа на конечни елементи (FEA), за утврдување на попрецизни работни оптоварувања и испитувања на дефекти.

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  • Itan Sunihciyi
    November 14, 2021 6:48 am



    ひずみゲージは、一時的なイベントや振動による動的ひずみを測定するためにも使用できます。 ひずみゲージ測定からの情報は、有限要素解析(FEA)モデルの検証に役立ち、より正確な動作負荷と故障調査を確立します。

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    应变仪也可用于测量由于瞬态事件或振动引起的动态应变。 来自应变仪测量的信息可用于验证有限元分析 (FEA) 模型、建立更准确的运行载荷和故障调查。

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