Developing, Verifying, and Validating IEC 62304 Compliant Code with MATLAB
Overview
Any algorithms built for safety-critical applications for medical devices require verification and validation (V&V). The formal testing methods are useful not only to ensure the quality of the algorithms developed, but also to help generate the artifacts required by the FDA for IEC 62304 certification or for general-purpose archiving. In this webinar, we'll use a case study from an AI-enabled wearable ECG monitoring device to present a V&V framework that can be applied to any algorithms built in MATLAB.
Highlights
Specific topics include:
- Introduction to systematic testing and the MATLAB test framework
- Establishing test-driven development workflows with interactive test authoring, execution, and management tools
- Measuring and optimizing code coverage
- Analyzing code quality and project-level health
- How to perform equivalence testing with generated C/C++ or deployed software components
- Tracking requirements and generating artifacts in support of certified workflows
- Automating MATLAB tests, artifact generation, and deployment in CI/CD systems, e.g. Azure DevOps
About the Presenter
Oscar Molina Ortiz
Senior Application Engineer
Oscar is part of the Application Engineering Team in Plano, TX. He has a solid background in computational fluid dynamics (CFD), finite element analysis (FEA), and numerical simulation in high-performance computing (HPC) environments. Oscar has extensive experience with developing performant code in MATLAB, C/C++, and Python, with a focus on data structures, algorithms, runtime/space complexity analysis, parallel computing algorithms, and optimization libraries for massively parallelizable models. Oscar holds a bachelor’s degree in Mechanical Engineering and master’s and PhD degrees in Petroleum Engineering.
