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TRUST SIGNALS
Key highlights of the appAuto-generate IEC 62304 compliance sub-tasks in Jira. Built for medical device software teams regulated under FDA and MDR
Auto-create compliance sub-tasks
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 8 regulatory standards
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.
Per-project control and backfill
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.
More details
Enable the app on any Jira project in one click. From that point on, every new issue in that project is scanned automatically — no rules to write, no spreadsheets to maintain.
When an issue is created, the app scans the summary and description for regulatory signals and creates detailed sub-tasks with step-by-step instructions mapped to the exact clause.
Covered standards:
• IEC 62304 — Full software lifecycle (§5.2 through §9)
• ISO 14971 — Risk management
• IEC 62366-1 — Usability engineering
• IEC 81001-5-1 / AAMI TIR57 — Cybersecurity
• ISO 13485 — Design change control
• 21 CFR Part 820 / MDR 2017/745 — Regulatory submissions
• HIPAA / GDPR — Data privacy
Each sub-task cites the exact clause, applicable safety class (A/B/C), and required DHF evidence. Compliance obligations surface in your existing Jira workflow — no context switching, no spreadsheets.
Resources
App documentation
Comprehensive set of documentation from the partner on how this app works
Privacy and Security
Privacy policy
Atlassian's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner.
Partner privacy policySecurity program
This app is not part of the Marketplace Bug Bounty program.
Integration permissions
MedTech Compliance Tracker integrates with your Atlassian app
Version information
Version 2.0.0•for Jira Cloud
- Release date
- May 13th 2026
- Summary
- initial release. covers 8 standards.
- Details
Enable the app on any Jira project in one click. From that point on, every new issue in that project is scanned automatically — no rules to write, no spreadsheets to maintain.
When an issue is created, the app scans the summary and description for regulatory signals and creates detailed sub-tasks with step-by-step instructions mapped to the exact clause.
Already have issues in the backlog? Use the built-in backfill tool to scan all existing issues and generate any missing compliance sub-tasks in one pass.
Covered standards:
• IEC 62304
• ISO 14971
• IEC 62366-1
• IEC 81001-5-1 / AAMI TIR57
• ISO 13485
• 21 CFR Part 820 / MDR 2017/745
• HIPAA / GDPREach sub-task cites the exact clause, applicable safety class (A/B/C), and required DHF evidence. Compliance obligations surface in your existing Jira workflow — no context switching, no spreadsheets.
- Payment model
- Paid via Atlassian
- License type
- Commercial