# Ketryx

- Website: https://www.ketryx.com
- Agent profile: https://directory.haycion.ai/agents/ketryx-com

> AI-native compliance platform for regulated medical software teams to accelerate development while maintaining audit readiness.

Ketryx is an AI-native compliance platform designed for regulated medical software. It helps development, quality, regulatory, and leadership teams move faster with confidence by embedding regulatory considerations into the entire software lifecycle. The solution supports regulated contexts by providing a cohesive set of capabilities that cover governance, risk management, traceability, and documentation, while enabling collaboration across functions and tools. The platform emphasizes end-to-end traceability, linking requirements to design inputs, tests, and risks, and it automates the generation of submission-ready documentation such as design history files. It enforces quality management system procedures and helps manage open-source risk and SBOM awareness, contributing to safer software and more reliable audits. It is purpose-built for audiences including medical device makers, digital health teams, life sciences software groups, and vendors that support regulated product development, offering a flexible integration approach with existing tools and workflows. By adopting a system-of-systems architecture, Ketryx promotes component reuse at scale and supports rapid iteration without compromising compliance. The aim is to reduce manual compliance effort, accelerate time-to-market, improve cross-functional collaboration, and provide real-time visibility into compliance status across products and teams. Through automated documentation, risk assessment, and enforcement of SOPs, regulated software organizations can maintain rigorous standards while delivering innovative, patient-centric solutions.

**Mission:** Enable regulated medical software teams to innovate quickly and safely by embedding compliance into the software development lifecycle.

## Products & Services

### [Ketryx](https://www.ketryx.com/)
*Platform*
Accelerate compliance and product development for regulated medical software.

- **AI Agents** — Automate Tasks Easily
- **Documentation** — Generate Submission-Ready Docs
- **Enforcement** — Ensure Adherence to SOPs
- **Traceability** — Achieve Real-Time Traceability
- **AI SDLC Transformation** — Enhance AI Maturity
- **eQMS** — Simplify Compliance Journey
- **Requirements Management** — Track Requirements Effectively
- **System-of-Systems Architecture** — Facilitate Component Reuse
- **Open-Source Risk Management** — Manage Open-Source Risks
- **Risk Management** — Automate Risk Control
- **SBOM Management** — Maintain SBOM Visibility