AssurX
16 Case Studies
Case Study: Nihon Kohden OrangeMed achieves rapid ventilator scale-up and regulatory-compliant quality to maximize patient safety with AssurX
A AssurX Case Study
Ventilator Manufacturer Scales with AssurX to Maximize Patient Safety and Build a Strong Brand
Nihon Kohden OrangeMed, a start‑up division focused on a newly designed ventilator, faced the challenge of replacing a paper‑based document system with a secure, scalable digital quality management system that would meet FDA and ISO requirements and connect all quality processes from the start.
They implemented a highly configured AssurX QMS (7‑month rollout with a 3‑month parallel validation), imported historical data, and added document, training, calibration, supplier, CAPA and complaint/MDR workflows. The system enabled rapid, compliant scale‑up during the COVID pandemic, supported 510(k) approval and multiple favorable global audits, reduced calibration overdue events, and delivered a single source of truth that strengthened patient safety and the company’s brand.
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