Ketryx

Learn what regulators actually expect from teams using Jira under IEC 62304 and how AI can close traceability gaps and automate critical documentation in Part 11-compliant workflows.

See how Dexcom automates live traceability and design control documentation without leaving their existing tools.

See how a frontier AI lab keeps safety and systems engineering on one set of requirements, while engineers stay in their existing tools.

🥽 Rapid iteration and regulatory rigor usually pull in opposite directions. For Meta's first 510(k), Reality Labs had to bring both together across hardware and software teams, from development through submission. On Thursday, November 5th, Liz Khalil and the Meta team share what changed in collaboration, tooling, and quality management to meet IEC 62304 while maintaining a best-in-class engineering culture. Register now 👇

⛓️💥 Agile moves fast, but Jira alone wasn’t built to meet the regulatory rigor required for medical device software. Under IEC 62304, that gap shows up as broken traceability, last-minute scramble to complete documentation, and endless manual copy-pasting. Join us on Wednesday, October 14th, for Jira for IEC 62304: Developing FDA-Compliant Software, one of our most popular webinars. Learn what regulators expect from teams operating under IEC 62304, and the common gaps that appear in real-world Jira implementations. Then discover how AI can reduce manual compliance work without weakening oversight. Register now👇

When outputs shift with every model update, taking screenshots of test evidence can’t scale. This session applies FDA CSA's risk-based principles to AI, covering intended use, human oversight, and reproducibility, on a validated Requirement Conflict Detection agent.