Case Study: Nihon Kohden OrangeMed scales ventilator production and strengthens compliance with AssurX

Nihon Kohden OrangeMed validates 65 DCNs in 7 months with AssurX

Nihon Kohden OrangeMed, a medical device manufacturer developing a new ventilator, needed to build a compliant quality management system from the ground up as a startup. They faced the challenge of moving beyond a basic paper-based system to a digital platform that could securely manage documentation and scale with their growth, ensuring compliance with regulations like FDA and ISO. To meet this need, they selected the AssurX quality management system.

The implementation of AssurX provided a single, connected platform for quality processes, beginning with document management and expanding to include training, supplier quality, and calibrations. The system proved critical during the COVID-19 pandemic, enabling Nihon Kohden OrangeMed to rapidly scale production while maintaining compliance, as new employees were trained quickly and all necessary documentation was readily available. The AssurX solution has successfully withstood multiple audits from global regulatory bodies and has electronically linked key processes like complaints to MDR reports, maximizing efficiency and patient safety.

Nihon Kohden OrangeMed