Your mission is to improve the life of millions - Ours is to make your mission easier
Matrix One integrates requirements management, design control, eQMS, eIFU, cloud connectivity, and AI-powered compliance tools to help life science organizations build, launch, and support better and safer products
Our Software Suite
Matrix One brings together every element of regulated product development, from design control to post-market documentation, in one secure, cloud-based system. Whether you’re managing requirements, quality events, eIFUs, or device connectivity, our AI-enabled solutions ecosystem keep your teams aligned and your compliance effortless.
A comprehensive eQMS platform that unifies quality processes, ensures compliance and drives continuous improvement
Jump to Quality
Manage all the laboratory activities in one platform in a seamless and GxP compliant way.
Jump to LIMS
Stay tuned - New features are coming soon
Learn more from our customers
Since our foundation in 2014, we have helped hundreds of Medical Devices Companies across their entire journey, from requirements management to product clearance and audit.
“With workflow automation we can import thousands of test cases from our third-party provider 95% faster than if we were performing the same work by hand.”
Jeff Miller, VP of Engineering
"With automation from MatrixALM, we reduced our human resource requirements by two full-time equivalents, while reducing regulatory timeline by 6 months"
Jon Giambattista, Director of Software
“I think VIPUN Medical has easily saved six months by working with Matrix Requirements to create efficient digital workflows.”
Carl Van Lierde, VP Product Development
“With the Matrix Requirements solutions, all employees enjoy access to up-to-date information, helping us to manage regulatory activities effectively.”
Carl Van Lierde, VP Product Development
“The time we saved was the most critical aspect of working with Matrix Connect. It would have been at least six months building cloud connectivity from scratch.”
Greg O'Grady - Co-Founder and CEO, Alimetry
“On top of them having the best solution in the industry, with Matrix Connect, for me, it's the people. They have built trust with our team, I trust them, and that is invaluable for us."
Emily Granger - Senior Marketing Officer, Delphi
Life science teams choose Matrix One because we turn regulatory complexity into a competitive edge. With automation, traceability, and AI-powered insight built in, you can focus less on documentation and more on discovery
Regulatory confidence
Built with compliance at the core. Meet FDA, MDR, and global regulatory requirements with confidence.
Accelerate innovation
Reduce time-to-market with streamlined workflows and automated compliance processes
Cross-functional collaboration
Unite R&D, Quality, Regulatory, and Operations teams on one unified platform
Get in touch with a Matrix One expert and discover how we connect compliance and innovation, so you can move from idea to impact, faster.