MedTech Compliance Tracker — Documentation

Overview​

MedTech Compliance Tracker is a Jira app for medical device software teams. When a new Jira issue is created, the app automatically detects regulatory obligations and creates compliance sub-tasks — each with step-by-step instructions mapped to the exact clause of the relevant standard.

No configuration is required other than enabling the app on a per-project basis. Install the app, enable it on relevant projects and it works immediately.

Requirements​

• Jira Cloud (classic or team-managed projects)
• An active MedTech Compliance Tracker license

Installation​

1. Go to the Atlassian Marketplace listing and click Get it now.
2. Select your Jira Cloud site and follow the installation prompts.
3. Accept the requested permissions:
   • Read Jira issues — to scan issue content for regulatory signals
   • Write Jira issues — to create compliance sub-tasks
4. Enable the app by navigating to Space Settings -> Apps -> MedTech Compliance Tracker Settings. The URL for this page is of the form https://your-account.atlassian.net/jira/software/c/projects/project-key/settings/apps/{appId}/{envId} [1].

How it works​

Every time a new Jira issue is created, the app:

1. Reads the issue summary and description.
2. Scans both fields for keywords associated with regulatory obligations.
3. Creates one sub-task for each matched compliance rule.

Each sub-task includes:

• A clear title identifying the standard and clause (e.g. ✅ Compliance: Update Software Requirements Specification (IEC 62304 §5.2))
• Step-by-step instructions for satisfying the obligation
• The applicable safety class (A, B, or C) and required evidence for the Design History File (DHF)

Sub-tasks are created as children of the original issue and appear immediately in the issue's sub-task list.

Covered standards and rules​

How rules are triggered​

The app scans the issue summary and description and may create multiple sub-tasks if the issue touches several regulatory areas. It is intentionally designed to err on the side of over-flagging rather than miss an obligation.

If a sub-task is not relevant to your ticket, simply delete it.

Behavior notes​

• Sub-tasks are ignored. The app does not process sub-tasks, only parent issues, to prevent recursive triggering.
• Multiple rules can fire on a single issue. A ticket about a UI bug fix may trigger rules for IEC 62304 §9 (Problem Resolution), IEC 62366-1 (Usability Engineering), and IEC 62304 §5.5 (Unit Verification) simultaneously.
• Classic projects: Sub-tasks are created using the project's dedicated sub-task issue type.
• Team-managed projects: Sub-tasks are created as child Tasks, since team-managed projects do not have a dedicated sub-task type.

Frequently asked questions​

Does the app store any of my Jira data? No. Issue content is processed in-memory within the Atlassian Forge runtime and is never written to any external system. See the Privacy Policy for details.

Can I customise the rules or keywords? Not in this version. The bundled ruleset covers the full IEC 62304 lifecycle and related standards applicable to most medical device software teams. Custom rules are planned for a future release.

What happens if the app creates a sub-task I don't need? Delete it. The app only runs on issue creation, so no new sub-tasks will be created for that issue unless it is re-created.

Does the app work on existing issues? Yes. Run the backfill tool to create compliance sub-tasks for existing issues. The backfill tool can be found under the app settings page - the same page that you use to enable or disable the app.

Support​

For questions or issues, contact: support@essofore.com