[Skip to main content](https://www.ketryx.com/blog/ado-integration#) .svg) [Blog](https://www.ketryx.com/learn/blog) [In the News](https://www.ketryx.com/about/newsroom) / Product Updates # Ketryx’s New Integration with Azure DevOps (ADO): End-to-End Traceability for Regulated Teams Milan Dzenovljanovic and March 20, 2025 [ADO](https://www.ketryx.com/learn/blog?tag=ado) [AI](https://www.ketryx.com/learn/blog?tag=generative-ai) [Traceability](https://www.ketryx.com/learn/blog?tag=traceability) ## Table of Contents [Why Integrate with ADO?](https://www.ketryx.com/blog/ado-integration#why-integrate-with-ado) [Making ADO Work for Regulated Teams](https://www.ketryx.com/blog/ado-integration#making-ado-work-for-regulated-teams) [How Ketryx Integrates with ADO](https://www.ketryx.com/blog/ado-integration#how-ketryx-integrates-with-ado) [See It in Action: Watch the Recorded Webinar](https://www.ketryx.com/blog/ado-integration#see-it-in-action-watch-the-recorded-webinar) [Get Started with the ADO Integration](https://www.ketryx.com/blog/ado-integration#get-started-with-the-ado-integration) [Related Posts](https://www.ketryx.com/blog/ado-integration#related-posts) One of the biggest challenges we see regulated teams face is coordinating work [across systems](https://www.ketryx.com/capabilities/integrations). Systems engineers and product marketing often use a dedicated tool to [manage requirements](https://www.ketryx.com/capabilities/requirements-management) and system-level validation activities, while their software teams rely on other tools like Azure DevOps (ADO) to manage their software development lifecycle (SDLC) and source code. Having work fragmented across multiple platforms creates major challenges in real-time visibility, end-to-end [traceability](https://www.ketryx.com/capabilities/traceability), [documentation](https://www.ketryx.com/capabilities/documentation), and adherence to [QMS processes](https://www.ketryx.com/capabilities/enforcement). That’s why we built a native [integration with ADO](https://docs.ketryx.com/integrations/azure-devops). Our new integration gives teams real-time visibility into all aspects of their product development lifecycle that are currently managed in Azure DevOps, enabling seamless QMS enforcement and traceability without having to leave ADO. With Ketryx, you can now [transform ADO into a 62304-compliant environment](https://www.ketryx.com/learn/webinars/register/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops) with automated traceability, integrated [risk management](https://www.ketryx.com/capabilities/risk-management), and instant evidence generation. End-to-End Traceability and Automated Documentation with the Ketryx Azure DevOps Integration 🔍 Click for sound See the ADO integration in action in this 2-minute video ‍ ## **Why Integrate with ADO?** We frequently talk to teams who [use Azure DevOps](https://docs.ketryx.com/integrations/azure-devops#id-4.-azure-devops-configuration) as their system for managing source code, running test pipelines, and tracking work items. However, we found that many of them were running into the same problems: - Manual effort to link requirements, code, and tests - Siloed risk management processes - Cumbersome documentation processes Some teams try to solve these problems with third-party extensions, but these often come with significant drawbacks. They require ongoing maintenance to stay compatible with ADO updates, frequently break, require regular validation, and may not scale well for large amounts of data. Plus, it’s tough to integrate them with other systems, like risk management tools. In light of these problems, we set out to build a **validated** integration with ADO that would provide automated traceability, automated documentation, integrated risk management, and 62304 compliance while allowing teams to work directly in ADO (instead of context-switching to use yet another platform). ## **Making ADO Work for Regulated Teams** Here’s how Ketryx’s integration with ADO solves common gaps in traceability, risk management, and documentation. ### **Automated Traceability Replaces Manual Linking** For regulated teams, every code change must be mapped to requirements, risks, and [test cases](https://www.ketryx.com/use-case/traceability-to-automated-tests). We found that many teams using ADO were doing this process manually through links, a process that was both inefficient and prone to error. Ketryx’s integration with ADO automates traceability so that you can easily identify traceability breaks and create links between items directly in ADO. - Every requirement, test, and change is [automatically linked](https://docs.ketryx.com/integrations/azure-devops#id-3.1.-q-how-does-ketryx-synchronize-azure-devops-data), eliminating manual traceability tasks. - The traceability matrix can be fully customized to match each team’s workflow: choose your rows and columns and watch the items flow in from ADO. - Configurable checks identify traceability gaps in real time to ensure compliance. - A local traceability widget embedded in ADO provides an accurate view of traceability between items—without having to leave ADO. Local traceability in ADO keeps developers in their development environment ### **Seamless Risk Management for TPLC Control** Teams using ADO told us that their risk management process was disconnected from their software development process, leaving them with uncontrolled risks. Ketryx’s integration with ADO integrates [risk management](https://www.ketryx.com/capabilities/risk-management) for a seamless experience, embedding risk-based engineering controls directly into ADO. - Teams get true many-to-many risk relationships and automated risk tracing directly within ADO. - [AI-driven](https://docs.ketryx.com/reference/ketryx-intelligence) risk analysis surfaces mitigations that need to be linked and validated. - Risk-based engineering [controls](https://www.ketryx.com/capabilities/enforcement) ensure that changes impacting risk are reviewed and approved before release. ### **Audit-Ready Documentation, Faster** Every day we hear stories of documentation requiring tedious manual effort. For example, teams working in ADO tell us they have to download their documentation in batches, which slows releases and increases audit risk. Ketryx’s integration with ADO [generates evidence as artifacts](https://docs.ketryx.com/manuals/man-01-ketryx-lifecycle-management#id-7.-records-and-artifacts) directly from the work you’re already doing in ADO, no additional steps required. As a result: - Teams can instantly generate DHF documents, trace reports, and risk matrices from ADO. - QA/RA teams can enforce their QMS directly in ADO so that every change is tracked, approved, and Part 11-compliant. - Fast document generation scales as the complexity of your projects increases. ## **How Ketryx Integrates with ADO** Here’s what teams can do today when they connect Ketryx to ADO. When working in ADO: - Create and manage specifications, tests, and other [configuration items](https://docs.ketryx.com/integrations/azure-devops#id-3.1.-q-how-does-ketryx-synchronize-azure-devops-data) directly through ADO and see all updates reflected in Ketryx in real time. - See [traceability](https://docs.ketryx.com/manuals/man-07-traceability) built into ADO to understand how ADO work items connect to requirements, tests, and risks regardless of the system they live in. Trace source code changes to requirements in ADO, with traceability reflected in both ADO and Ketryx. - Trace ADO items to other [systems of work](https://www.ketryx.com/capabilities/integrations) like Jama, Polarion, and Git-based repositories like Azure Repos, Bitbucket, GitHub, and Gitlab. When working in Ketryx: - View, manage, and filter ADO work items directly within Ketryx on the All Items screen, Traceability screen, and Risk Management screen. - Run structured [KQL queries](https://docs.ketryx.com/reference/ketryx-query-language) to search for ADO work items on the All Items and Traceability screens in Ketryx, as well as in document templates. - Define [custom configuration items](https://docs.ketryx.com/integrations/azure-devops#id-3.2.-q-can-i-customize-how-ketryx-maps-azure-devops-fields-and-work-item-links) to align ADO work items with IEC 62304 and configure how data in ADO maps to Ketryx, including item types, fields, and relation types. - Use ADO items as [risk controls](https://docs.ketryx.com/manuals/man-08-risk-management) on the “Edit risk” screen in Ketryx, marking those items as risk controls that are visible throughout Ketryx. ## **See It in Action: Watch the Recorded Webinar** To showcase how teams can leverage ADO for IEC 62304 compliance and AI/ML-enabled software development, we hosted a free webinar: [**ADO for IEC 62304 and AI: Developing FDA-Compliant Software in Azure DevOps**](https://www.ketryx.com/learn/webinars/register/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops) **. Watch the recording** [**here**](https://www.ketryx.com/learn/webinars/register/ado-for-iec-62304-and-ai-developing-fda-compliant-software-in-azure-devops) **.** ## **Get Started with the ADO Integration** Connecting Ketryx with ADO is simple. Head to the [Connections page](https://docs.ketryx.com/integrations/azure-devops) in Ketryx or talk to your Client Operations Manager to set up your integration and start experiencing seamless traceability today. Want to see it in action? [Schedule a demo](https://www.ketryx.com/schedule-demo) and let our team show you how Ketryx and ADO work together to streamline compliance and accelerate development. ## **Related Posts** - [Modernizing FDA-Grade Software Development with Validated DevOps](https://www.ketryx.com/white-papers/validated-devops-white-paper) - [A Guide to Implementing CI/CD in Your AI/ML SaMD Projects](https://www.ketryx.com/white-papers/ci-cd-ai-ml-white-paper) [Read the full article](https://www.ketryx.com/blog/ado-integration#) ### Interview transcript Milan Dzenovljanovic Milan is one of the lead developers at Ketryx. He formerly worked as a Principal Software Engineer at Bitpanda, where he led a group of more than 100 engineers. ### Explore Our Top Blog Posts \\ \\ Traceability\\ **Why Change Impact Assessment Is the Hidden Bottleneck in Medical Device Development**\\ \\ Megan Mannino\\ \\ and \\ \\ •  \\ \\ February 19, 2026](https://www.ketryx.com/blog/change-impact-assessment-bottleneck) \\ \\ News video\\ **Watch how Ketryx applies AI to automate compliance in regulated software**\\ \\ CIO\\ \\ and \\ \\ CIO\\ \\ •  \\ \\ February 11, 2026](https://www.ketryx.com/blog/watch-how-ketryx-applies-ai-to-automate-compliance-in-regulated-software) \\ \\ In the News\\ **Use of AI in imaging paves the way for other medical devices**\\ \\ Ketryx\\ \\ and \\ \\ Boston Business Journal\\ \\ •  \\ \\ July 31, 2025](https://www.ketryx.com/blog/use-of-ai-in-imaging-paves-the-way-for-other-medical-devices)