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
6 Specialized AI Agents:
In everyday DevTools, like:
Stay in modern DevTools
Ketryx deeply and natively integrates with best-in-class DevTools like Jira, GitHub, GitLab, and AWS, so your developers don’t need to leave their preferred tools.
See integrations
Enforce QMS processes
Ketryx acts as a quality agent across all connected systems, coaching and enforcing your QMS processes directly in your preferred DevTools.
Explore enforcement
Establish traceability
Ketryx creates a real-time traceability matrix by overlaying product development tools and connecting all items, risks, code, and tests.
Explore traceability
Automate documentation
Ketryx generates Part 11-compliant evidence and a submission-ready DHF from the work being done in your preferred DevTools.
Explore documentation
Release faster
Release safer software faster using automation to generate documentation, establish traceability, and streamline processes.
Watch Recorded Demo
Watch How Ketryx Simplifies Traceability for MedTech.
- Orchestrate releases across dev tools
- Automatically generate required documentation (DHF)
- Enforce your procedures across dev tools
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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.”
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
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
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Planning & Research
Define project scope, objectives, and gather user requirements, while conducting preliminary market and technical research.
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Risk Analysis
Identify potential risks associated with the software and assess their impact on patient safety and product performance.
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Design
Create detailed software architecture and design specifications, ensuring compliance with regulatory standards.
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Develop
Write and compile the code based on design specifications, integrating necessary functionalities.
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Deploy
Install the software on the intended hardware or platform for initial testing and use.
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Test
Conduct thorough testing, including unit, integration, and system tests, to verify software functionality and reliability.
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Verification & Validation
Confirm that the software meets all specified requirements and intended use through rigorous testing and evaluation.
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Final Risk Analysis
Reassess risks post-development to ensure all potential hazards have been mitigated or controlled.
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Release
Prepare and approve the software for market release, ensuring all regulatory and quality requirements are met.
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Distribution
Distribute the software to end-users or customers, ensuring proper documentation and support are provided.
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Postmarket Surveillance
Monitor the software's performance and safety in the market, gathering user feedback and addressing any issues or updates needed.
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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.
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