Jira for IEC 62304: Developing FDA-Compliant Software - Ketryx Compliance Framework
Jira for IEC 62304: Developing FDA-Compliant Software
60
minutes
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In this rebroadcast of one of our most popular webinars, learn what regulators expect from teams using Jira to develop medical device software under IEC 62304. In real-world Jira implementations, the gaps show up as broken traceability, last-minute scrambles to complete documentation, and endless manual copy-pasting. See where those gaps appear and discover 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 signatures and approvals at the right steps in your workflow