Automatic regulatory sub-tasks for every Jira ticket

MedTech Compliance Tracker scans each new ticket, identifies which regulatory obligations apply, and generates the sub-tasks your team needs — before work starts.

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The gap it closes

When your team creates a new Jira ticket for a software change, who makes sure the right IEC 62304 sub-tasks get attached before work starts? At most MedTech companies it's either a manual checklist, a QA review step that slips, or nothing — and the gap shows up at audit time.

How it works

The moment a ticket is created, MedTech Compliance Tracker scans the summary and description, identifies which regulatory obligations apply, and generates detailed sub-tasks — each citing the exact clause, safety class (A/B/C), and required DHF evidence.

No rules to configure. No spreadsheets to maintain.

Coverage

  • IEC 62304
  • ISO 14971
  • IEC 62366-1
  • IEC 81001-5-1
  • ISO 13485
  • 21 CFR Part 820
  • MDR 2017/745
  • HIPAA
  • GDPR

Rollout, on your terms

Enable it on exactly the Jira projects under regulatory scope. A one-click backfill catches anything already sitting in the backlog.

Resources

Try it free Questions? Contact us