Ketryx Connected Lifecycle Management Platform

Ketryx is a connected lifecycle management platform designed for life science and medical device software teams building FDA-regulated products. It is built around a developer-first approach, integrating directly with existing development tools such as Jira, GitHub, GitLab, AWS, and Polarion, and is designed to support compliance with IEC 62304, GMP, ISO 13485, and 21 CFR Part 820/11.

The platform uses six specialized AI agents that operate across connected DevTools to automate compliance tasks, enforce quality management system (QMS) processes, generate documentation, and maintain traceability — all while keeping developers working in their preferred environments. Human review is retained for all AI-recommended changes.

AI Agent Capabilities

• Integrates with DevTools including Jira, GitHub, GitLab, and AWS to analyze work as it happens and capture compliance context automatically.
• Acts as a quality enforcer across connected systems, coaching developers in real time and flagging deviations from QMS processes.
• Generates a living traceability matrix that continuously maps requirements, risks, and tests, with AI detecting gaps and proposing missing links or risk controls.
• Automates 21 CFR Part 11–compliant documentation by drafting evidence, suggesting links, and updating files throughout the development cycle.
• Supports release activities by drafting documentation, recommending traceability links, performing change impact analysis, and automating postmarket surveillance tasks.

Software Development Lifecycle (SDLC) Coverage

Ketryx supports regulated software teams across the full software manufacturing process, from early planning through postmarket surveillance. Each phase is connected within the platform:

1. Planning and Research: Defines project scope, objectives, and user requirements while supporting preliminary market and technical research.
2. Risk Analysis: Identifies potential risks associated with the software and assesses their impact on patient safety and product performance.
3. Design: Supports creation of software architecture and design specifications in alignment with regulatory standards.
4. Develop: Connects to development environments where code is written and compiled based on design specifications.
5. Deploy: Tracks installation of software on intended hardware or platforms for initial testing and use.
6. Test: Supports unit, integration, and system testing to verify software functionality and reliability.
7. Verification and Validation: Confirms that software meets specified requirements and intended use through testing and evaluation.
8. Final Risk Analysis: Reassesses risks post-development to confirm that potential hazards have been mitigated or controlled.
9. Release: Manages preparation and approval of software for market release, ensuring regulatory and quality requirements are met.
10. Distribution: Supports distribution to end-users with appropriate documentation and support.
11. Postmarket Surveillance: Monitors software performance and safety in the market, gathering user feedback and addressing issues or updates.

Platform Features

• AI Agents for automated compliance analysis and documentation drafting.
• Automated testing integration across the SDLC.
• Requirements management connected across development systems.
• Risk management tools covering initial and final risk analysis phases.
• Software Bill of Materials (SBOM) generation and tracking.
• Traceability matrix maintained continuously across requirements, risks, and tests.
• Electronic QMS (eQMS) enforcement directly within preferred DevTools.
• Broad integrations with tools including Jira, GitHub, GitLab, AWS, and Polarion.

Ketryx is positioned for regulated product teams in life sciences and medical device development. The platform targets organizations seeking to reduce the time required to establish and maintain FDA-compliant software infrastructure, with the stated goal of keeping development teams audit-ready throughout the product lifecycle.