Jira for IEC 62304: Developing FDA-Compliant Software

January 6, 2026, 11:00 am EST • 60 mins

Recorded on January 6, 2026 • 60 mins

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. This webinar breaks down what regulators expect from teams operating under IEC 62304, the common gaps that appear in real-world Jira implementations, and how AI can reduce manual compliance work without weakening oversight.

What you'll learn

• Ways to use AI to identify and close traceability gaps before you discover them during release prep
• Strategies to automate SRS, SDS, V&V, and other critical documentation from live Jira data with AI-assisted evidence generation
• How to collect Part 11–compliant e-signatures and approvals at the right steps in your workflow

Clips from this Webinar

Speakers

Jenn Dixon

Director of AI Quality & Regulatory Strategy Ketryx Formerly

Gabriel Pascualy

Head of Product Ketryx Formerly Principal Investigator, MITRE