Case Study: VIPUN Medical achieves ISO 13485 certification and faster regulatory readiness with Matrix Requirements

VIPUN Medical targets better outcomes for ICU patients

VIPUN Medical, a medical device start-up from Belgium, faced the challenge of needing an efficient application lifecycle management (ALM) and quality management system (QMS) to bring its innovative gastric monitoring solution for ICU patients to market without documentation delays. Their paper-based processes were time-consuming and threatened to slow down their crucial regulatory certification efforts. They turned to the solutions from vendor Matrix Requirements to address this.

By implementing Matrix Requirements' integrated MatrixALM and MatrixQMS solutions, VIPUN Medical replaced its manual workflows with efficient digital ones. This provided full traceability for design and risk management. The results were significant: the company saved an estimated six months of manual work and successfully achieved ISO 13485 certification. Matrix Requirements' solution provided the streamlined, auditable system needed to instill confidence in regulators and avoid documentation becoming a blocker.

VIPUN Medical

Carl Van Lierde

Vice President Product Development