Case Study: Cognoa achieves faster FDA-compliant development and test traceability with MatrixALM from Matrix Requirements

Cognoa harnesses AI to enable earlier diagnosis of childhood behavioral conditions

Cognoa, a pediatric digital health startup, faced the challenge of transforming its app into an FDA-authorized medical device, requiring a design control system to ensure full traceability in its development process. To achieve this, they turned to vendor Matrix Requirements and implemented their MatrixALM application lifecycle management solution.

Matrix Requirements' MatrixALM provided an agile platform for managing requirements, specifications, and tests. The solution enabled Cognoa to automate the import of thousands of test results from external partners, maintaining full traceability and cutting test case management time by 95%. This allowed the company to efficiently validate approximately 5,000 test cases per release cycle and successfully achieve market authorization for its AI-powered diagnostic aid.

Cognoa

Jeff Miller

Senior Director, Head of Engineering