In Silico Design Verification – Mehor Solutions

In Silico Design Verification

High-fidelity computational evidence generation for risk-informed medical device development.

In Silico Design Verification replaces traditional “trial-and-error” bench testing with high-fidelity computational modeling.

We create a high-resolution Digital Twin of your device within its intended human environment, providing predictive insights and robust regulatory documentation that physical testing cannot match.

CORE ENGINEERING SPECIFICATIONS

ASME V&V 40 Compliance: Every simulation is performed within the ASME V&V 40 framework, ensuring computational modeling is “credible” and “validated” for formal FDA regulatory submissions.

1mm “Accurate” Tier Modeling: We utilize 1mm STL-derived body models to eliminate the margins of error introduced by the 2mm or 4mm approximations common in the industry.

Massive Parallel Execution: Our 2TB RAM HPC cluster executes massive parametric sweeps and “worst-case” scenarios that standard workstations cannot process.

Multi-Physics Integration: Simultaneous validation of EM safety, and SAR distribution in a single unified environment.

DELIVERABLES: THE REGULATORY RUNWAY

Action: Use these to define the “FDA-ready” artifacts provided to the client.

Worst-case Analysis (WCA): Identify safety failures (lead heating/SAR spikes) across a 99th-percentile patient population.

Sensitivity & Uncertainty Quantification: Statistical proof that the device meets safety standards despite manufacturing tolerances or patient variability.
Performance Optimization: Fine-tune antenna matching and power transfer efficiency where every tissue variable is controlled and measured.