Ketryx provides an AI-native platform for Application Lifecycle Management (ALM) tailored for regulated medical device software development. The platform automates traceability, risk management, and documentation generation to ensure continuous compliance with standards like FDA, EU MDR, and ISO. This integration allows R&D teams to maintain development velocity while producing submission-ready Design History Files (DHF).
Funding
$14M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Developing regulated medical applications, especially those involving AI/ML, is complex and time-consuming due to stringent FDA, EU MDR, and ISO compliance requirements. Quality and R&D teams face challenges in managing validation across various DevTools, open-source libraries, and software versions, leading to slower time to market and increased costs. The manual effort required for tracking requirements, documenting changes, and enforcing regulations creates a significant bottleneck.
Solution
Ketryx offers a connected lifecycle management platform that streamlines the development of regulated medical applications by automating documentation, establishing real-time traceability, and enforcing quality management system (QMS) processes. The platform integrates with popular DevTools like Jira, GitHub, and GitLab, allowing developers to stay within their preferred environment while ensuring compliance. Ketryx uses AI agents to automate tasks across the toolchain, generating Part 11-compliant evidence and submission-ready design history files (DHFs) directly from the work being done. This approach reduces the documentation burden, accelerates release cycles, and ensures continuous compliance throughout the software development lifecycle (SDLC).
Target Audience
The primary users are quality professionals, R&D leaders, and AI/ML leaders at MedTech companies who need to accelerate development, ensure compliance, and reduce the complexity associated with regulated medical device software.
Features
- AI Agents: Automate tasks across the toolchain while maintaining human oversight for safety-critical operations.
- Real-time Traceability: Automatically create a requirements traceability matrix by connecting items, risks, code, and tests from connected systems.
- Automated Documentation: Compile requirements, design inputs/outputs, and tests into configurable, submission-ready DHFs.
- QMS Enforcement: Enforce QMS processes directly within preferred DevTools.
- Software Bill of Materials (SBOM): Provide a consolidated view of the open-source supply chain directly from source code.
- Vulnerability Management: Automate vulnerability detection to quickly evaluate risk.
- Integrations: Natively integrate with DevTools such as Jira, GitHub, GitLab, and AWS.
- Risk Management: Control and document risks in compliance with ISO 14971.
- Version Control: Compare changes between versions using the release dashboard.