The Context

In the Medical Device industry, Traceability is not optional—it's the law. Managing thousands of requirements, risks, and test cases in Excel was a recipe for disaster. We needed a system that could enforce ISO 13485 compliance programmatically.

The System

I architected a custom Quality Management System (QMS) dashboard that links Design Inputs to Validation Outputs automatically.

• Automated Traceability MatrixPython scripts parse design documents and generate real-time coverage reports.
• Audit-Ready LogsImmutable audit trails stored in SQL to satisfy FDA/ISO auditors.
• Dockerized DeploymentContainerized the entire stack for easy on-premise deployment in secure hospital networks.