Matrix One (formerly Matrix Requirements) is a global leader in software solutions for medical device manufacturers (Medical Devices and Software as/in Medical Device – SxMD) and life sciences companies. Their mission is to help innovative organizations develop safer products, faster, while simplifying regulatory compliance.

Their intuitive, flexible, AI-powered solutions ensure quality and traceability across the entire product lifecycle.

Matrix One’s solutions

• Matrix Req: A design control software for product development teams, with advanced AI capabilities to support requirements management, quality oversight, risk management, and regulatory standards compliance. Matrix Req works seamlessly with Matrix QMS to provide full traceability and smooth integration with quality processes.
• Matrix QMS (formerly Simploud): A compliant cloud-based quality management system that enables organizations to manage all quality processes, from audits to CAPA, incident and document management. Matrix QMS and Matrix Req together link design and quality, providing a comprehensive view of the product lifecycle.
• Matrix Connect (formerly Galen Data): A secure, compliant cloud solution designed for connected medical devices, enabling seamless data collection, management, and protection.
• Matrix eIFU (formerly Dokspot): A fully compliant electronic Instructions For Use (eIFU) solution enabling manufacturers to securely publish, manage, and update electronic documentation in multiple languages, in line with global regulatory requirements.

Founded in 2015 by medical device experts, Matrix One now has a team of over 40 employees based across Germany, France, Belgium, the United Kingdom, the United States, and Spain.