ASME Releases New Technical Report Expanding on V&V 40 Framework

Originally published in 2018, ASME V&V 40 introduced a risk-informed framework for assessing the credibility of computational models used in medical device regulatory submissions. The standard defines structured processes for:

• Model verification

• Validation

• Applicability assessment

• Credibility goal setting

• Risk-based evidence requirements

Since then, V&V 40 has become a widely recognized reference for model-informed medical device development and regulatory engagement.

The newly released VVUQ40.1:2026 technical report does not replace the 2018 V&V 40 standard. Instead, it provides a practical, worked example demonstrating how to implement the framework in a real-world context.

Key features of the new report include:

• A detailed case study:  Tibial Tray Component Worst-Case Size Identification for Fatigue Testing

• Step-by-step application of the credibility assessment process

• Practical interpretation of risk-based evidence requirements

• Expanded guidance on documentation and justification of modeling assumptions

This publication offers valuable clarity for organisations seeking to operationalise V&V 40 within product development and regulatory strategies.