How to Build Compliant Software Faster with Polarion, Jira, and Ketryx
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Medical device software is growing in complexity, driven by AI/ML, mobile applications, cloud connectivity, and increasingly modular architectures. At the same time, software team productivity in MedTech has remained nearly flat—rising just 2% annually (McKinsey).
To keep up, organizations are adopting agile practices and modern development tooling like Jira, GitHub, and CI/CD pipelines. But these tools weren’t built for regulated environments. They lack native support for traceability, risk management, and documentation aligned with standards like IEC 62304.
Many teams turn to Polarion as a tool that can manage the entire lifecycle of their regulated products. But in reality, software developers working in Polarion still rely heavily on tooling like Jira to work in an efficient, agile way.
How can MedTech teams bridge this gap?
Why It’s So Hard to Use Polarion with Jira in Agile Development
Teams working across Jira and Polarion often face the following issues:
- Poor support for parallel development and testing
Teams tell us that it's difficult to develop and test software versions in parallel, especially when different teams are using different tools that don't talk to each other. - Lack of visibility across the full system
Regulated teams struggle to see traceability from user needs in Polarion down to code and test artifacts in tools like Jira, GitHub, and TestRail. - Manual copy/pasting for documentation
The majority of teams we talk to are still manually copying work from Jira into Polarion just to generate compliant documentation for audits or releases.
These challenges stem from the fundamental disconnect between tools designed for velocity (Jira) and tools designed for structure and compliance (Polarion). Syncing data isn’t enough—teams need to orchestrate the full IEC 62304 lifecycle across tools.
Achieving End-to-End Traceability Across Jira and Polarion
An integration between Polarion and Jira should do more than sync data. It should support real-time traceability and interoperability across tools so teams can:
- Trace a Jira user story up to a system requirement in Polarion, and down to software specs in Git or test cases in Xray
- Execute approvals in Jira with a consistent audit trail, with all data synced to Polarion in real time
- Manage baseline versions, approve changes, and ensure trace impact is visible throughout the lifecycle
Traceability between items housed in different tools should be bidirectional and actionable—not just a static export or spreadsheet. To enable this, Ketryx acts as a layer of abstraction over tools like Jira and Polarion, orchestrating 62304 compliance in an agile way across your toolchain.
Accelerating IEC 62304 Compliance with AI Agents
Ketryx AI Agents help you enforce compliance, maintain documentation integrity, and surface traceability gaps—while keeping full control in your hands. Agents continuously scan across your connected systems to find the things humans miss, suggest improvements, and act with your approval.
- Test Coverage Agent: Recommends traceability relationships between Jira stories, tests, and Polarion requirements
- Change Request Review Agent: Verifies that every change request in Jira has all the appropriate fields filled out, and generates resulting risks in Polarion
- Conflict Detection Agent: Flags redundant or conflicting requirements across projects in Jira, Polarion, and other connected tools
These agents reduce documentation overhead, support continuous delivery, and keep development aligned with evolving regulatory expectations—including the FDA’s Predetermined Change Control Plan (PCCP) framework.
Explore how Beacon Biosignals used PCCPs to ship AI updates biweekly →
Build Compliant Software Faster—Without Duplicating Work
Medical device software teams don’t have to choose between speed and compliance. With Ketryx orchestrating 62304 compliance throughout your toolchain, you can:
- Let developers work in Jira, Git, and CI/CD tools
- Let quality and regulatory teams stay in Polarion
- Connect everything automatically into one compliant, traceable system
To learn more, watch our recent webinar on how to use Jira and Polarion with Ketryx for agile development.
