Regulatory Compliance

ASME V&V 40: The Standard for Computational Credibility

At Mehor Solutions, we don’t just provide data; we provide credibility. We follow the ASME V&V 40 framework—the industry standard for Assessing Credibility of Computational Modeling through Verification and Validation. This ensures that the In Silico evidence we generate is robust enough to support your “Context of Use” (CoU) in formal regulatory submissions.

CORE COMPLIANCE SPECIFICATIONS

- Verification (Code & Calculation): Rigorous internal checks ensuring the physics are solved correctly using our 1mm “Accurate” Tier geometric resolution.
- Validation (Model & Physics): Correlating simulation results with physical bench data to ensure the Digital Twin accurately predicts real-world human interaction.
- Uncertainty Quantification (UQ): Providing the rigorous statistical analysis required by regulators to define the margins of safety and sensitivity of the model.
- HPC Traceability: Leveraging our 2TB RAM HPC cluster to perform the exhaustive parametric sweeps required to prove safety across a diverse patient population.

By strictly adhering to ASME V&V 40, we transform computational models into formal safety artifacts.

Our process helps you navigate the FDA’s increasingly rigorous expectations for computational data in 510(k), De Novo, and PMA submissions. We identify and mitigate “Model Risk” early, ensuring your In Silico evidence stands up to the scrutiny of a formal regulatory audit.