Matrix Req (formerly Matrix Requirements) is a collaborative, AI-powered software explicitly built to meet the rigorous needs of medical device development. It helps cross-functional teams design, build, and launch high-quality medical devices while maintaining complete, end-to-end traceability of requirements, risks, and tests. The platform automates the cumbersome audit preparation process by generating structured documentation and trace matrices directly from live data, reducing regulatory submission timelines from weeks to days. Trusted by over 500+ life sciences companies, Matrix Req ensures that compliance is built-by-design rather than treated as an afterthought.
A startup from Germany.
Requirements Traceability
Automated end-to-end trace matrices from system specifications to test protocols and code commits.
Risk Management
Document, analyze, and mitigate product risks in compliance with ISO 14971 standards.
DHF Compilation
Compile Design History Files (DHF) and Technical Files automatically with robust version control.
Matrix Req is built specifically for highly regulated medical device developers rather than general software teams. It natively bridges the gap between agile development (e.g., Jira workflows) and strict compliance requirements (ISO 13485, IEC 62304) by automating end-to-end trace matrices, risk management (ISO 14971), and Design History File (DHF) compilation in real time.
Matrix Requirements was founded in Germany in 2014 by Yves Berquin and Wolfgang Huber, two computer scientists with deep medical device development experience. Having felt firsthand the pain of keeping technical documentation audit-ready manually, they bootstrapped the company to create an agile, developer-friendly platform that automates administrative compliance and accelerates time-to-market for health innovations.
Legacy requirements tools are often heavy, expensive, and require teams to adopt rigid, outdated workflows. Matrix Req offers a lightweight, modern, and collaborative cloud-native alternative. It integrates seamlessly into existing developer toolchains (Jira, GitHub, GitLab, Azure DevOps) so engineers can keep using the tools they love while quality teams automatically generate compliant documentation in the background.
The primary audience includes medical device manufacturers, SaMD (Software as a Medical Device) developers, systems and software engineers, quality assurance (QA) professionals, and regulatory affairs (RA) managers who need to streamline compliance and maintain constant audit readiness.
Matrix Req is a modern cloud-based SaaS platform built on secure, highly scalable web technologies. It utilizes end-to-end data encryption and robust API layers to enable seamless, bidirectional integrations with mainstream developer platforms including Jira Software, GitHub, GitLab, and Microsoft Azure DevOps.
Global medical device manufacturers (MDMs)
Innovative Software as a Medical Device (SaMD) startups
Healthcare IoT and digital health solution providers
Regulatory consulting firms and clinical research organizations (CROs)
Medical technology research institutes and university medical departments
Matrix Req (matrixone.health) appears to be a niche healthcare/requirements management platform; without independent, verifiable reviews or extensive user data available, it seems to offer targeted functionality for health-related process or requirements tracking, but potential users should verify current features, pricing, and support quality directly before committing.
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