Ketryx

Ketryx provides AI-native compliance and application lifecycle management software for teams developing regulated products. Its platform connects development work with quality and regulatory processes, helping organizations maintain traceability, manage risk, enforce procedures, and prepare audit-ready documentation without requiring developers to leave their preferred tools. Ketryx supports products including software as a medical device, connected devices, AI-enabled medical products, and integrated hardware-software systems.

The company’s capabilities include requirements and risk management, automated traceability across requirements, code, tests, and risks, software bill of materials management, and automated compilation of Design and Development Files. Its tools also include AI agents and assistants, change-impact assessment, eQMS functionality, and integrations that can turn Jira into a validated environment for medical-device software development. Ketryx addresses standards and regulations such as IEC 62304, ISO 13485, ISO 14971, GMP, FDA requirements, the EU Medical Device Regulation, the EU AI Act, and the EU Cyber Resilience Act. The platform is designed to help regulated teams accelerate development while maintaining compliance and product quality.