Verification and Validation

SIMULIA utilizes ISO 9001:2008 certified processes for verification and benchmarking for the development of its simulation software applications.

See the Abaqus Verification Guide and the Abaqus Benchmarks Guide for published problem suites. These same processes for verification and validation were applied to the Heart Model.

This page discusses:

Verification

Verification is a process to establish and confirm that the results from a simulation model reproduce those from an associated mathematical model. Verification includes unit testing, convergence studies, and computational platform testing.

SIMULIA has developed a suite of four problems that verify the implementation of the constitutive equations for the electrical and mechanical passive and active response of the cardiac tissue. These problems are available upon request.

Validation

Validation encompasses quality assurance and model correctness activities surrounding the development of a simulation model and the custom software components it utilizes or contains. Validation activities specific to the Heart Model are described below.

Model Validation

Model Validation encompasses comparison against generally expected behavior (e.g., measured against published and generally accepted metrics like pressure-volume loops, ECG traces, overall motion, etc.). The simulation results presented in the table in Summary of Simulation Results represent the current status of SIMULIA's quantitative Heart Model validation.

Intended Use Validation

Intended Use Validation is a part of the overall validation for a procedure or treatment that will often involve specific medical devices. Intended use validation is confirmation by the provision and examination of objective evidence that the model is predictive for each specific intended use. A conclusion that the model is validated for its intended use is highly dependent upon comprehensive testing, inspections, data analyses, and simulation result comparisons against measurement data.

SIMULIA has not performed any Intended Use Validation on the Heart Model and recognizes that it will not be suitable for all applications.