Software teams building medical devices run their development work in Jira, where the engineering detail behind user needs, requirements, outputs, verification, and validation often takes shape. Greenlight Guru's new Jira integration brings engineering documentation into the eQMS automatically, creating design controls from matching Jira issues and pushing approval status back to Jira once the quality team signs off.
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Design control records that form while engineering works
Design controls under 21 CFR Part 820 and ISO 13485 require traceable links from user needs through design inputs, outputs, verification, and validation, along with evidence that a qualified person reviewed and approved them. Software teams generate those links continuously. A requirement gets refined mid-sprint, a test case moves, a defect reopens a story that closed two weeks ago.
Our Jira integration keeps the two records aligned automatically, rather than in a batch before a design review or a submission deadline. Engineers can write requirements and close issues in Jira the way they already do, and the design controls in Greenlight Guru reflect that work without anyone entering it a second time.
Set up mirroring with a JQL query and field mapping
Our Jira integration is configured per product. A Jira Query Language (JQL) query defines which Jira issues become design controls, so a team can match on issue type, on a label, or on any other criteria JQL supports. When an issue matching that query is created in Jira, Greenlight Guru creates the corresponding design control.
Field and link mapping determines what carries across, including standard or custom Jira fields, so records arrive populated instead of as stubs. Design controls created through the integration are view-only, which keeps Jira as the single place the content is authored and prevents the two systems from drifting apart through parallel edits.
Approvals travel back to Jira
Approval works in the other direction. When a design control is approved in Greenlight Guru, the integration posts a comment on the originating Jira issue and can optionally transition that issue's status. The engineer who wrote the requirement sees the sign-off in the tool they were already working in.
Choose which design control types come from Jira
Not every team keeps every kind of evidence in Jira. Verification and validation records often live in a test management tool, a lab notebook, or the quality system itself, even when user needs and design inputs are managed in Jira.
Mirroring is configured per design control type for that reason. A team can mirror user needs and design inputs from Jira automatically while leaving other types without a mirroring rule when those records are managed elsewhere.
Built for product development and quality teams
With this feature, product development leads get a design control record that keeps pace with their release cycle, without asking engineers to learn and maintain a second system alongside Jira. For teams building software as a medical device, where release cadence and documentation cadence are furthest apart, the time savings will be substantial.
At the same time, quality managers get the same record without the collection work. What remains is judgment. A reviewer reads what came across, decides whether a requirement is verifiable, and approves it. Approval visibility runs both ways, so the design and development file stays current and engineering learns the outcome without a status meeting.
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Try our Jira integration today
Our Jira integration is available now, and your customer success manager can walk you through the JQL and field mapping setup for your projects.
If you aren't a Greenlight Guru customer, then get your free demo to see how design controls, risk, and quality records work together for software teams.
Keep reading
If you are connecting engineering work in Jira to your design controls, these related guides go deeper on the specific components:
Cybersecurity Gap Assessment Checklist
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