ASME V&V40 | EndoLab Finite Element Analysis

Historically, regulatory bodies participating in the evaluation of orthopaedic implants (e.g. US FDA, TÜV, BSI) have been reluctant to accept the results of Computational Model and Simulation (CM&S) studies such Finite Element Analysis (FEA) in supporting product submissions. The primary concern has been regarding the accuracy, validity, and assessing the credibility of the results.

In the first attempt to standardize the use of FEA in orthopaedics, ASTM published ASTM F2996-13 in 2013, which provides guidance using FEA to determine the worst-case sized hip stem to test in a product family based on maximum principal stress. Then, physical testing would be performed on that stem. Therefore, the results used in ASTM F2996-13 are assumed to provide rank‑order data, not necessarily accurate stress data.

In 2014, US FDA published their first draft guidance regarding the verification and validation requirements for CM&S studies. The final version was issued in 2016; however, the guidance was very rudimentary with sparse details.

In 2018, the American Society for Mechanical Engineers published ASME V&V 40, which is very comprehensive and provides a method for determining the appropriate level of Verification and Validation (V&V) activities based on the context and scope for which the CM&S data will be used. The development of ASME V&V 40 included the participation of the largest orthopaedics companies in the world, smaller orthopaedics companies, FEA software companies, universities, independent laboratories, national laboratories, military personnel, federal government personnel, and US FDA. ASME V&V 40 is the current state-of-the-art for assessing the credibility of CM&S.

This Standard Operating Procedure (SOP) describes the process for performing a risk-informed credibility assessment when performing CM&S in accordance with ASME V&V 40.

It is not possible to fully encompass, in enough detail, each situation that will need a decision during a CM&S study, and this document will continue to grow and evolve. ASME V&V 40 provides many examples for the decision-making process to be in compliance.

Is ASME V&V 40 a test standard?

No. ASME V&V 40 is not a test standard. Instead, it defines a structured approach for verification and validation (V&V) of computational models and simulations (CM&S) used to support the design and regulatory assessment of medical devices.

Where does ASME V&V 40 apply?

ASME V&V 40 applies when simulation results are used to support regulatory submissions, particularly when physical testing is limited or not available. In some cases, physical testing may still be required to support specific verification and validation (V&V) activities.

Does ASME V&V 40 replace physical testing?

Not entirely. With an appropriate level of verification and validation, simulation can reduce reliance on physical testing in certain cases by helping to manage and mitigate risks.

How do regulators view ASME V&V 40?

While ASME standards are less commonly referenced in orthopaedics than ASTM or ISO standards, the principles of ASME V&V40 are well aligned with established regulatory expectations. Its risk-based approach closely mirrors design control requirements and the quality management principles of ISO 13485. As a result, even if a regulatory authority is not explicitly familiar with ASME V&V40, they can readily understand its intent and recognize its value as a structured and credible framework for risk mitigation.

Can ASME V&V 40 be combined with ISO and ASTM testing?

Absolutely! This is a common and recommended approach. Physical testing under ISO and ASTM standards can be used alongside ASME V&V 40 to provide complementary evidence for verification and validation, particularly when evaluating worst-case scenarios.

What level of model credibility is required under ASME V&V 40?

There is no one-size-fits-all answer. The required level of model credibility depends on the question of interest (QoI). ASME V&V40 recommends a risk-based approach, where the credibility is determined by considering the intended use of the model, the potential consequences of errors, and the established credibility goals.

ASME V&V 40

Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices

Normative References