MedTech Compliance Tracker
Auto-generate IEC 62304 compliance sub-tasks in Jira.
MedTech Compliance Tracker launched on June 2, 2026 with 4 votes, #3,322 of 22,647 launches that month and more than 75% of that year's launches.
What it does
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.
Auto-generate IEC 62304 compliance sub-tasks in Jira. Built for medical device software teams regulated under FDA and MDR
The moment a Jira ticket is created, the app scans it and generates compliance sub-tasks — each with step-by-step instructions, the exact IEC 62304 clause, applicable safety class, and required evidence. Covers IEC 62304, ISO 14971, IEC 62366-1, IEC 81001-5-1, ISO 13485, 21 CFR Part 820, MDR 2017/745, and HIPAA/GDPR. Every sub-task cites the clause and safety class so nothing slips through audit. Enable the app on exactly the projects under regulatory scope. Already have issues in the backlog? The built-in backfill tool scans all existing issues and generates any missing sub-tasks in one pass. Enable the app on any Jira project in one click. From that point on, every new issue in that…from marketplace.atlassian.com
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