# 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](/content/learn/webinars/register/jira-for-iec-62304-jan-25#/index.html)

Formerly

### Gabriel Pascualy

Head of Product

[Ketryx](/content/site-root.html)

Formerly

Principal Investigator, MITRE

## Interested?

[Register now](/content/learn/webinars/register/jira-for-iec-62304-jan-25#register/index.html)