ASME V&V 40-2018 PDF

Full title and description

V&V 40 — Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices. This ASME standard provides a risk‑informed framework for establishing and communicating the credibility of computational models used to support medical‑device design, evaluation and regulatory decisions, by relating required verification, validation and applicability evidence to the model’s context of use and model risk.

Abstract

ASME V&V 40–2018 presents a structured, risk‑based approach for assessing whether the verification, validation and uncertainty quantification (VVUQ) activities performed for a computational model are adequate for the intended Context of Use (COU). The standard defines credibility factors, ties the required level of rigor to model influence and decision consequence, and provides a framework to communicate model credibility to stakeholders (including regulators). It complements ASME V&V methodology standards (e.g., V&V 10, V&V 20) rather than prescribing specific numerical methods.

General information

• Status: Placed on stabilized maintenance (current edition remains in effect).
• Publication date: 2018 (published November 2018).
• Publisher: The American Society of Mechanical Engineers (ASME).
• ICS / categories: 11 (Health care technology) — particularly 11.040 (Medical equipment / medical devices) and related healthcare IT classes.
• Edition / version: V&V 40 — 2018 edition.
• Number of pages: 60 pages (ISBN 9780791872048).

Scope

Provides a general framework to assess the relevance and adequacy of completed V&V and applicability activities for computational models used in medical‑device contexts. The scope covers establishing the model’s Context of Use and Question of Interest, identifying model risk (combination of model influence and decision consequence), selecting credibility factors and gradations of evidence, and documenting how the assembled evidence meets the credibility requirements for a given decision. The standard was developed for medical devices but is general enough to be applied in other disciplines.

Key topics and requirements

• Context of Use (COU) and Question of Interest (QOI): define precisely what the model is intended to support.
• Model risk assessment: combine model influence with decision consequence to determine required credibility.
• Credibility factors: a set of factors (e.g., verification, validation, applicability, input/data characterization, uncertainty quantification) used to judge model credibility.
• Graduated evidence/rigor: select gradations of VVUQ activities commensurate with assessed model risk (higher risk → greater evidence/rigor).
• Documentation and communication: clearly report the COU, model description, evidence gathered, acceptance criteria and residual uncertainties to support stakeholder review and regulatory submissions.
• Complementary role: augments methodology standards (ASME V&V 10, V&V 20, VVUQ terminology documents) rather than prescribing specific numerical techniques.

Typical use and users

Used by modeling and simulation practitioners, biomedical engineers, regulatory affairs specialists, quality and validation teams, and researchers within medical‑device companies and consultancies. It is also used by regulatory agencies and reviewers as a recognized framework for assessing model evidence in submissions. Typical applications include FEA for implant durability, CFD for hemodynamics, and other physics‑based in‑silico evaluations that support design decisions or regulatory claims.

Related standards

ASME V&V 10 (computational solid mechanics), ASME V&V 20 (computational fluid dynamics and heat transfer), VVUQ 1 (terminology), and other VVUQ technical reports and annexes that provide methods and metrics for verification, validation and uncertainty quantification. The ASME V&V 40 framework is referenced in recent FDA guidance on computational modeling and simulation for medical device submissions.

Keywords

Verification; Validation; Uncertainty Quantification (UQ); Credibility assessment; Context of Use (COU); Model risk; Computational modeling; In silico; Medical devices; Regulatory submission.

FAQ

Q: What is this standard?

A: ASME V&V 40–2018 is a risk‑informed framework standard for assessing and communicating the credibility of computational models used in medical‑device development and regulatory decisions. It defines credibility factors and links required VVUQ evidence to the model’s intended Context of Use.

Q: What does it cover?

A: It covers definition of the Context of Use and Question of Interest, model risk assessment (model influence × decision consequence), selection of credibility factors, gradation of VVUQ rigor appropriate to model risk, and expectations for reporting and documentation. It does not prescribe specific numerical techniques for every application.

Q: Who typically uses it?

A: Modeling and simulation engineers, validation leads, regulatory and quality personnel in medical‑device manufacturers and consultancies, plus regulatory reviewers who evaluate modeling evidence in submissions. Researchers and academics applying VVUQ to medical devices also use it as a reference framework.

Q: Is it current or superseded?

A: The 2018 edition is the current ASME V&V 40 standard and has been placed on stabilized maintenance by ASME (the product page indicates the 2018 version remains in effect). Additionally, FDA guidance published subsequently recognizes and recommends the use of ASME V&V 40 to support credibility arguments in regulatory submissions. Users should check ASME and regulatory announcements for any future revisions or companion technical reports.

Q: Is it part of a series?

A: Yes — V&V 40 is part of ASME’s Verification, Validation and Uncertainty Quantification (VVUQ) family of standards and is intended to be used with ASME V&V 10, V&V 20 and other VVUQ documents that provide detailed methods and terminology.

Q: What are the key keywords?

A: Verification, validation, uncertainty quantification, credibility, context of use, model risk, in silico, computational modeling, medical device, regulatory submission.