[Skip to main content](https://www.ketryx.com/product#) [](https://www.ketryx.com/product#) This is some text inside of a div block. Meet the Ketryx Platform # AI-powered lifecycle management for life science teams The only developer-first connected lifecycle management platform built to use your preferred tooling [Preview Product](https://app.ketryx.com/auth/signup) 6 Specialized AI Agents: In everyday DevTools, like: ### AI across your DevTools Ketryx AI Agents interoperate with your DevTools like Jira, GitHub, GitLab, and AWS—analyzing work as it happens and capturing compliance context automatically. Developers stay in flow while AI handles the regulatory lift. [See integrations](https://www.ketryx.com/capabilities/integrations) ### AI-driven QMS enforcement Ketryx AI Agents act as quality enforcers across all connected systems. They coach developers in real time, flag deviations, and automatically enforce QMS processes directly in your preferred DevTools. [Explore enforcement](https://www.ketryx.com/capabilities/enforcement) ### AI-powered traceability Ketryx generates a living traceability matrix—continuously mapping requirements, risks, and tests. AI Agents detect gaps, propose missing links, and suggest risk controls before auditors ever see the file. [Explore traceability](https://www.ketryx.com/capabilities/traceability) ### AI-generated documentation Ketryx generates Part 11–compliant documentation in the background. Ketryx AI Agents draft audit-ready evidence,  suggest traceability, and auto-update DHFs as your team codes, tests, and reviews. [Explore documentation](https://www.ketryx.com/capabilities/documentation) ### AI-accelerated releases Release safer software faster with AI Agents that draft documentation, recommend traceability links, perform change impact analysis, and automate postmarket surveillance—all while your team focuses on innovation. [Watch Recorded Demo](https://www.ketryx.com/product#) # Watch How Ketryx Simplifies Traceability for MedTech. - Orchestrate releases across dev tools - Automatically generate required documentation (DHF) - Enforce your procedures across dev tools [Book a live demo](https://www.ketryx.com/schedule-demo) .png) Ketryx 15m Demo 5.1.25 Click for sound ●●●●●●●●●●●●●●●●●●●●●●● Introduction to the Ketryx Platform Integrating Additional Tools Adding a New Feature Modifying Requirement Specifications Peer Review and Approval Process Reviewing Specifications Finalizing Specification Updates Updating Test Cases Reviewing Changes for Next Version Approving Test Case Changes Understanding Traceability Checks Identifying Anomalies in the Release Leveraging Anomaly Review Agents Documenting Anomaly Findings Executing Test Cases in Jira Finalizing Test Execution Approvals Managing Risk Controls Reapproving Risks with Updated Controls Summary of Release Changes Generating Release Documentation Reviewing Incremental Release Reports Verifying Traceability Matrix Conclusion of the Demonstration  15 Minutes Gabriel Pascualy Director of Solutions, Ketryx > “The fewer tools that my developers have to worry about, the better, because they should be worrying about saving people's lives.” Allan Snippen VP of Engineering Navigating Compliance with AI ## Agentic AI for Regulated Product Teams Working with knowledge of your QMS, Ketryx AI Agents connect to your tools (like Jira, GitHub, and Polarion) to detect issues, draft documentation, and recommend actions, always surfacing changes for human review. [Learn more about AI Agents](https://www.ketryx.com/capabilities/ai-agents) Automated and traceable ## Manage your SDLC across systems Developing regulated software is complex. Ketryx connects across your systems to impose control on preferred DevTools throughout the lifecycle, from planning to post-market. ## Software Manufacturing Process .svg) ### Planning & Research Define project scope, objectives, and gather user requirements, while conducting preliminary market and technical research. See how it works: [AI Agents](https://www.ketryx.com/capabilities/ai-agents) [Automated Testing](https://www.ketryx.com/use-case/traceability-to-automated-tests) [Documentation](https://www.ketryx.com/capabilities/documentation) [Enforcement](https://www.ketryx.com/capabilities/enforcement) [eQMS](https://www.ketryx.com/capabilities/eqms) [Integrations](https://www.ketryx.com/capabilities/integrations) [Requirements Management](https://www.ketryx.com/capabilities/requirements-management) [Risk Management](https://www.ketryx.com/capabilities/risk-management) [SBOM](https://www.ketryx.com/capabilities/sbom-software-bill-of-materials) [Traceability](https://www.ketryx.com/capabilities/traceability) ### Risk Analysis Identify potential risks associated with the software and assess their impact on patient safety and product performance. See how it works: ### Design Create detailed software architecture and design specifications, ensuring compliance with regulatory standards. See how it works: ### Develop Write and compile the code based on design specifications, integrating necessary functionalities. See how it works: ### Deploy Install the software on the intended hardware or platform for initial testing and use. See how it works: ### Test Conduct thorough testing, including unit, integration, and system tests, to verify software functionality and reliability. See how it works: ### Verification & Validation Confirm that the software meets all specified requirements and intended use through rigorous testing and evaluation. See how it works: ### Final Risk Analysis Reassess risks post-development to ensure all potential hazards have been mitigated or controlled. See how it works: ### Release Prepare and approve the software for market release, ensuring all regulatory and quality requirements are met. See how it works: ### Distribution Distribute the software to end-users or customers, ensuring proper documentation and support are provided. See how it works: ### Postmarket Surveillance Monitor the software's performance and safety in the market, gathering user feedback and addressing any issues or updates needed. See how it works: ## FDA-ready software, without the hassle Contact us to see how Ketryx can accelerate your development time by up to 10X while keeping your team audit-ready. [Book a demo](https://www.ketryx.com/schedule-demo)