Case Study: PulmoTech achieves faster medical device regulatory approval with Matrix Requirements

PulmoTech drives down risk of lung injury for ventilated patients in intensive care

PulmoTech, a medical device startup, sought to bring its innovative Esophageal Pressure Catheter to market while managing a complex regulatory approval process. With a lean team, their challenge was to efficiently handle strict traceability, quality management, and documentation requirements without getting bogged down by manual processes. They turned to Matrix Requirements and implemented its MatrixReq solution to address this need.

By deploying the integrated MatrixReq solution, PulmoTech digitalized its quality management, automated the traceability of requirements, and streamlined regulatory submissions. As a result of working with Matrix Requirements, the company achieved zero major non-conformities on its initial audits, enhanced team collaboration, and successfully completed a high-quality MDR submission on time with its small team.

PulmoTech

Rutger Flink

CEO and Founder