Founded in 2014 by Wolfgang Huber (former VP R&D at Advanced Medical Diagnostics and co-founder of NeoMed Software) and Yves Berquin (former Program Manager at Advanced Medical Diagnostics and CTO at SleepOnWeb), Matrix Requirements has grown into a leader in the MedTech quality management system software space with two highly differentiated solutions :
- MatrixALM, flexible software for managing medical device technical files with the goal of accelerating regulatory approvals (CE marking, FDA approval, etc.) and reducing non-compliance risk
- MatrixQMS, a quality management system solution enabling MedTech companies to develop and maintain their own quality systems reflecting the specific needs of their products in compliance with ISO and FDA standards.
To date, these solutions have been adopted by more than 180 MedTechs throughout the world, including large accounts (Stryker, BBraun, Roche, Sanofi…), start-ups (Mindmaze, UgenTec, Robocath…) and academic institutions (University of Arkansas). Matrix Requirements addresses customer needs with a growing team of engineers and MedTech quality management system experts specialized in medical devices. Matrix Requirements is ISO13485 and ISO 27001 certified.
“Yves and Wolfgang have built remarkable MedTech quality management system products that delight customers and accelerate time to market for life saving medical devices. The MedTech eQMS software market exceeds $2.5 billion in size and is growing rapidly as software replaces paper and regulatory scrutiny grows. We are excited to work hand in hand with the Matrix management team to strengthen the company’s commercial engine and enable our customers to navigate rigorous audits without non-conformities.”
Samuel Levy, Founding Partner at Lauxera