Establishing
traceability for your medical device software is complex
Both R&D and Quality teams say traceability is hard. It’s an interconnected maze spanning tools, people, document types, and versions.
Your requirements and architecture live in Jira or other DevTools, while your software detailed design and automated tests live in your Git repository. So how do you trace across different systems?
Build traceability from your existing systems
Turn your medical device software development into traceability
Ketryx atomizes traceability and automatically creates relationships across systems to make it clear that you've got no coverage gaps.
See local traceability in Jira
Ketryx creates local traceability within Jira, so developers can trace every new item to at least one other item.
Trace requirements and automated tests directly from your code repository
Automate traceability across all requirements, design inputs/outputs, and tests in Git.
Easily view complex systems of systems in your traceability matrix
Top-level projects can pull in items from other projects to give you a comprehensive view of your microservice architecture.
Track changes between versions
Manage requirements and see a full history of changes in Jira or your tool of choice.
Stay audit-ready with FDA-compliant medical device traceability
Ketryx automatically maintains a real-time requirements traceability matrix across all connected systems so it’s always up-to-date, no manual work required.