Open Source Summit + Embedded Linux Conference North America 2026

When software can directly affect whether someone lives or dies, "move fast and break things" isn't an option. But does that mean safety-critical software can't be open source? Tidepool's experience building Tidepool Loop - an FDA-cleared, open-source automated insulin delivery (AID) system for people with Type 1 diabetes - proves it can.

This talk explores how Tidepool developed an open-source quality management system (QMS) that achieves full requirements traceability and testability while preserving the collaborative, transparent ethos of open-source development. We'll walk through the real-world challenges of mapping regulatory requirements to code contributions, maintaining traceability across a distributed contributor base, and building test infrastructure that satisfies both FDA expectations and open-source community standards.

Attendees will leave with a practical framework for applying requirements traceability and verification practices to open-source projects operating in regulated or safety-critical domains from medical devices to automotive systems to critical infrastructure.