Auto-generate IEC 62304 compliance sub-tasks in Jira. Built for medical device software teams regulated under FDA and MDR. Every time a new Jira issue is created, the app scans it and automatically creates compliance sub-tasks — each with step-by-step instructions tied to the exact clause of the relevant standard. No interruptions. No context switching. Your team sees what's required right alongside the work itself. No configuration required. Install, enable it on your project, and it works.
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Maker
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Hi All, I am excited to announce the launch of MedTech Compliance Tracker — a Jira app built for medical device software teams.
In most organizations, regulatory compliance is a pre-launch checklist. It happens at the end, when it's most
expensive to fix. The goal of this app is to change that — by making compliance part of everyday workflow, one
ticket at a time.
Here's how it works: every time a new Jira issue is created, the app scans it and automatically creates compliance
sub-tasks — each with step-by-step instructions tied to the exact clause of the relevant standard. No
interruptions. No context switching. Your team sees what's required right alongside the work itself.
Out of the box, it covers:
- IEC 62304 (full software lifecycle)
- ISO 14971 / IEC 62366-1 (risk & usability)
- IEC 81001-5-1 / AAMI TIR57 (cybersecurity)
- HIPAA / GDPR (data privacy)
- 21 CFR Part 820 / MDR 2017/745 (regulatory submission impact)
- ISO 13485 and more
No configuration required. Install, enable it on your project, and it works.
A free trial is available. Check it out on the Atlassian Marketplace:
https://marketplace.atlassian.co...
Questions or feedback welcome — drop a comment or reach out directly. Thanks for your love and support!
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