Case Study: a privately held medical device company achieves FDA Class C compliant US market entry with VOLANSYS pump console development

FDA Class C Software Development for a Pump Console

VOLANSYS partnered with a leading medical device company that needed to develop an FDA Class C compliant pump console to penetrate the US market. The client required an experienced healthcare partner to build this regulated system for extracorporeal blood circulation procedures.

VOLANSYS designed and developed the full pump console solution, which included a Linux-based QT application for monitoring vital signs and integrated STM32 and TI ARM modules for pump and sensor control. The solution was rigorously developed to comply with FDA Class C and IEC 62366 standards. This allowed the client to successfully enter the US market with their new, compliant medical device.