Case Study: Gabi SmartCare accelerates pediatric device certification with MatrixALM from Matrix Requirements

Gabi SmartCare enables real-time pediatric monitoring at home

Gabi SmartCare, a Belgium-based MedTech start-up, needed to accelerate the regulatory approval process for its innovative pediatric home monitoring device and software without compromising on quality or compliance. The challenge was to define product requirements early and manage complex design objects to avoid time-consuming re-work. To achieve this, they selected the MatrixALM solution from Matrix Requirements.

By implementing MatrixALM, Gabi SmartCare gained a single source of truth for requirements, specifications, and risk management. The solution's integration with GitLab enhanced collaboration between development and design teams. Matrix Requirements enabled the company to generate compliant documentation rapidly, resulting in a 15% improvement in development efficiency and an estimated 30% faster creation of traceability reports, speeding their path to FDA submission.

Gabi SmartCare

Nathalie Bosschaerts

Product Development Manager