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Ketryx

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Regulatory Compliancewww.ketryx.comUpdated

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

Overview

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 statement

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

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What we offer

Ketryx

Accelerate compliance and product development for regulated medical software.

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More information about our offering

Ketryx

Ketryx is an AI-native compliance platform for regulated medical software. It embeds regulatory considerations into the entire software lifecycle, helping development, quality, regulatory, and leadership teams move faster with confidence. The platform provides end-to-end governance, risk management, traceability, and documentation, enabling collaboration across functions and tools. It automatically generates submission-ready documentation such as design history files, enforces QMS procedures, and helps manage open-source risk and SBOM visibility, supporting a system-of-systems architecture for rapid, compliant iteration.

  • Automate Tasks Easily
    Using AI agents, Ketryx automates labor-intensive tasks within the software development lifecycle, ensuring efficiency while keeping a human in the loop for critical decisions.
  • Generate Submission-Ready Docs
    Effortlessly create necessary documentation for regulatory submissions, reducing manual effort and ensuring compliance with standards.
  • Ensure Adherence to SOPs
    Ketryx ensures that all teams adhere to their established Standard Operating Procedures, minimizing deviations and risks.
  • Achieve Real-Time Traceability
    Ketryx connects items, risks, codes, and tests, facilitating real-time traceability to support accountability and compliance.
  • Enhance AI Maturity
    Ketryx provides expert support to enhance your AI capabilities, ensuring your software development lifecycle is both efficient and compliant.
  • Simplify Compliance Journey
    Utilize an electronic Quality Management System tailored to integrate seamlessly with existing tools and processes.
  • Track Requirements Effectively
    Efficiently manage and trace requirements throughout the development process, linking them to tests and risks.
  • Facilitate Component Reuse
    Through its architecture, Ketryx allows for rapid development and iteration by promoting reuse of components across various projects.
  • Manage Open-Source Risks
    Ketryx supports awareness and management of open-source software components, enhancing security and compliance.
  • Automate Risk Control
    Automatically oversee and document risks in compliance with ISO 14971, ensuring safety and regulatory adherence.
  • Maintain SBOM Visibility
    Ketryx enables comprehensive views of your software supply chain, ensuring transparency and accountability for open-source components.

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