Release Notes
Reference library for Ketryx release notes
2.14
Ketryx 2.14
We’re excited to announce the launch of Ketryx 2.14, a release centered on accelerating agile development with powerful AI-driven workflows. New features directly support and enhance the story-driven development pattern for medical device software, ensuring that compliance is a natural part of the process, not a final hurdle.
This release focuses on accelerating development by embedding compliance directly into your agile workflow, supporting processes like those following AAMI TIR 45, as illustrated below:
Intelligent Quality Assurance
AI Agent Findings: Proactive Quality Management
You can catch quality issues before they impact your timeline. Create filters that automatically surface items that have been flagged by an AI Agent. Common use cases include:
For Product Managers: Stories are automatically flagged if they lack sufficient documentation or if the requirements, risks, or tests they might impact haven't been updated yet.
For System Engineers: Requirements are checked against established standards (like INCOSE guidelines) and flagged if they don't meet quality criteria. Updates are also suggested.
For Test Engineers: Easily identify test coverage gaps and ensure test cases align with requirement changes. The AI can also suggest changes if they do not.
Each flagged item includes actionable recommendations that can be reviewed, accepted, or dismissed. By addressing these suggestions, you ensure the item meets the necessary quality and traceability criteria.
Enhanced Assistant Capabilities: Your Intelligent Compliance Partner
You can have contextual conversations that build on previous discussions. Chat sessions now persist, so you can continue complex change impact analyses across multiple conversations without starting over.
You can customize the Assistant's behavior for your specific workflows. Create assistant rules files that guide behavior for different item types. For example:
For software requirements: You can ask it to always check for testability criteria, suggest verification methods, and flag requirements without acceptance criteria.
For risk items: It can ensure mitigation strategies are defined, while checking for residual risk assessment, and verify control effectiveness measures.
You can analyze code change reviews and their quality impacts in one workflow. For projects with connected repositories, you can ask the Assistant to look at pull requests and ask questions like ”Create a new requirement based on the pull request."
Seamless Cross-Platform Collaboration
Improved Information Access Through Traceability Widget’s “Detail View”
Stay focused without breaking your flow. The enhanced traceability widget view brings critical context directly into your detail view, letting you assess the status, key metadata, and content of connected items. Instead of jumping between windows or opening countless tabs, you have the full picture right where you’re already working.
By surfacing key connections at a glance, the widget makes it easier to assess progress, understand dependencies, and catch potential risks early. The result? Faster decisions, fewer distractions, and greater confidence that nothing slips through the cracks.
How to access the traceability detail view
Jama
Structure and folder mapping as relations in Ketryx
You can now maintain your existing Jama hierarchy workflow to establish traceability. Teams who prefer working with folder structures and hierarchical relationships can now capture Jama hierarchy as relations in Ketryx. If you're a systems engineer who thinks in terms of system-subsystem-component hierarchies, you can maintain that mental model while still creating traceability links. Ketryx is now able to support both approaches simultaneously.
Scope Jama synchronization with filters
You can now use Jama filters to subset items as they synchronize to Ketryx, and connect one Jama project to multiple Ketryx projects. This enhances your ability to manage your design controls as a System of Systems to enable rapid releases and granular configuration control, without needing to refactor your items in Jama. Teams that manage many items, versions, or product lines in Jama simultaneously no longer need to choose between visibility and compartmentalization.
Push comments from Ketryx to Jama
You'll never miss critical feedback or approval decisions. When you submit items for review in Ketryx, all invalidation, approval, and rejection comments automatically appear in your Jama environment. Your Jama-based team members can see the full context of decisions without switching tools, and reviewers working in Ketryx can be confident their feedback reaches the right people.
Jira
Parent-child hierarchy mapping in Ketryx
You can maintain your familiar epic and story workflow while building compliance traceability. If your team works in traditional Jira epic/story hierarchies, those parent-child relationships now integrate directly with Ketryx traceability. As your development team continues to work in Jira, they can start with a user story, trace this up to the epic and then connect this to requirements, risks and tests without having to log in to a different system.
Configurable QMS Enforcement
Custom Design Input/Output Controls: Precision Compliance
You can enforce approval workflows exactly as your QMS specifies. Configure different enforcement levels for different item types. For example, require strict sequential approval for requirements (design inputs must be approved before design outputs), while allowing flexible approval order for change requests and anomalies. Your compliance process matches your actual quality system instead of forcing your QMS into rigid tool constraints.
How to use granular control with design filters
Custom Risk Schemas: Model Risk Your Way
You can capture exactly the risk information each process requires. Different risk sources need different data so you now have the ability to configure multiple schemas, for example:
FMEA Teams capture failure modes, effects, and detection methods
Software Safety Teams record hazard classifications and safety integrity levels
Cybersecurity Teams document threat vectors and attack surface analysis
All risk types maintain full traceability to design controls and affected items, keeping risk management integrated throughout your SDLC.
How to use custom risk schemas
Additionally, the risk management widget is enabled by default on custom item types with the "Risk" category. If you need to selectively enable or disable the widget for specific risk types (e.g., show it only for custom risk types but not the standard risk type), configure it by the granular widget control.
How to configure the risk management widget
Enhanced Vulnerability and Dependency Management
Advanced Vulnerability Dispositioning
You can manage vulnerabilities across your entire product portfolio efficiently. If you maintain multiple versions of the same product:
Reuse Dispositions: Apply the same vulnerability assessment across similar product versions
Create Variants: When an older version remains vulnerable but newer versions are protected, create disposition variants instead of starting from scratch
Configure Scoring Profiles: Set up CVSS rescoring profiles based on your established rubrics and the system suggests appropriate scores as you work through dispositions
Streamline Calculations: Use the integrated CVSS calculator without switching to external tools
Flexible CycloneDX SBOM ingestion
You can leverage your existing security tool chain. Import any metadata from your CycloneDX SBOMs directly into custom fields, whether that's end-of-life information, support status, or enrichment data from your security scanners. This information becomes fully traceable and reportable within your quality workflows.
Operational Efficiency
Streamlined Team Management
You can onboard entire teams in minutes. Upload a CSV file with multiple team members and their group assignments directly to the platform, streamlining the onboarding process as your organization scales.
How to add your team to Ketryx
Optimized synchronization between Azure DevOps and Ketryx
Your Azure DevOps work items are now synced to Ketryx with enhanced performance. This optimization reduces synchronization times and eliminates the need for occasional manual refresh cycles.
This release delivers powerful enhancements designed to streamline your development processes, strengthen compliance, and improve overall operational efficiency. We are committed to continuously evolving Ketryx to meet your needs, enabling you to achieve higher quality and faster releases. Reach out to us with questions or feedback on these new features.
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