# 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

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### Clips from this Webinar

## Speakers

### Jenn Dixon

Director of AI Quality & Regulatory Strategy

[Ketryx](https://www.ketryx.com/learn/webinars/register/jira-for-iec-62304-jan-25#)

Formerly

### Gabriel Pascualy

Head of Product

[Ketryx](http://www.ketryx.com/)

Formerly

## Interested?

[Register now](https://www.ketryx.com/learn/webinars/register/jira-for-iec-62304-jan-25#register)