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Open Source Summit + Embedded Linux Conference North America... has ended
May 18-20, 2026
Minneapolis, MN
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Note: The schedule is subject to change.

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Wednesday May 20, 2026 2:10pm - 2:50pm CDT
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.
Speakers
avatar for Tapani Otala

Tapani Otala

VP, Engineering & Information Security Officer, Tidepool
Tapani has delivered innovative consumer electronics and cloud services over a 30+ year career. Before joining Tidepool in 2018, he was Sr. Director of Engineering at Samsung Research America, building cloud services for SmartTV and mobile apps. Prior to Samsung, he grew and led global... Read More →
Wednesday May 20, 2026 2:10pm - 2:50pm CDT
200C (Level Two)
  Safety-critical Software
  • Audience Experience Level Any
  • Slides Attached Yes

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