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FDA Class C Software Development for a Pump Console

FDA Class C Software Development

Client Overview

A privately held medical device company providing advanced cutting-edge medical solutions

Business Need

  • To penetrate the US market, the client was looking for an experienced partner in the healthcare domain who can help them in developing the FDA compliant pump console system

VOLANSYS Contribution

  • Designed pump console for licensed physicians & specialists to perform extracorporeal blood circulation procedures
  • Performed on the required process needed for FDA Class C medical device software development
  • Developed a pump driver module & control display functionality, complying with IEC 62366 standard
  • Integrated STM32 based module with a pump control system to control the pump
  • Integrated TI ARM chip to control & monitor the sensor equipped in the system
  • Designed a Linux based multi-threaded QT application to display temp., blood pressure, & actual measure blood flow
  • Visual and audio alerts when sensor values are beyond the set threshold 

Solution Diagram

Pump Console System

Benefits Delivered

  • Delivered IEC 62366 and FDA Class C compliant solution enabled the client to penetrate the US market with their standalone pump console solution

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Success Stories