Ketryx

Ketryx is an AI-powered compliance and application lifecycle management (ALM) platform designed for regulated product development, with a focus on medical device manufacturers and other life sciences organisations. The platform connects software development workflows with regulatory requirements, supporting standards including IEC 62304, ISO 13485, GMP, 21 CFR Part 820, and 21 CFR Part 11, as well as EU MDR. Ketryx is used by four of the top five medical device manufacturers and is positioned to reduce documentation burden by up to 90% while enabling faster release cycles.

The platform allows development teams to continue working in their existing tools — including Jira and GitHub — while Ketryx automatically generates traceability links and regulatory documentation in the background. Users report release cycles up to ten times faster, approximately 600 hours saved per engineer per year, and significantly reduced manual effort in compiling quality and technical documentation.

Core Platform Capabilities

• AI-Generated Documentation: Ketryx automatically produces compliant technical documentation as development work progresses, reducing the need for manual report compilation and keeping documentation current with minimal effort.
• Agentic AI for Continuous Compliance: AI agents monitor and enforce compliance requirements continuously throughout the software development lifecycle (SDLC), rather than as a point-in-time activity.
• Self-Tracing SDLC: The platform automatically tracks every requirement, risk, and test, maintaining real-time traceability across the development process without requiring engineers to manually maintain traceability matrices.
• QMS Enforcement: Quality management system (QMS) processes are enforced within the platform, reducing reliance on manual duplication of quality-related documentation and ensuring controls are applied consistently.
• Regulatory Release Support: Ketryx is designed to help teams ship FDA-compliant software faster by combining AI agents with built-in compliance controls, supporting accelerated release timelines.

Integrations and Workflow Compatibility

• Ketryx integrates directly with tools such as Jira and GitHub, updating compliance records and traceability data as engineers work within those environments.
• The platform is designed so that development teams do not need to change their existing workflows; compliance activities are handled by Ketryx in the background.
• The integration approach is described by users as enabling greater productivity and faster releases compared to managing compliance separately from development tooling.

Regulatory Standards and Compliance Coverage

• IEC 62304 (medical device software lifecycle processes)
• ISO 13485 (quality management systems for medical devices)
• 21 CFR Part 820 (FDA quality system regulation)
• 21 CFR Part 11 (electronic records and signatures)
• EU MDR (European Medical Device Regulation)
• GMP (Good Manufacturing Practice)

Customers and Use Cases

• Ketryx serves quality leaders, R&D teams, regulatory affairs professionals, and engineering organisations within regulated industries, particularly medical device development.
• Customers include organisations such as Heartflow, whose VP of Regulatory Affairs and Quality Systems noted the platform's ability to migrate a monolithic ecosystem into a structured project within days due to its scalability.
• Quality assurance directors, risk and compliance managers, and heads of product and engineering are among the roles cited as direct users of the platform.
• The platform is described as suitable for teams needing to maintain agile development practices while satisfying regulatory requirements.

Ketryx positions itself as a validated, single platform that removes the trade-off between development speed and regulatory compliance, making it applicable to any organisation building software-driven products in regulated life sciences environments.