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FDA Compliant Dosage Infusion Pump Solution for Leading US-Based Medical/Healthcare Company

Banner IoT Product Testing Embedded Engineering Healthcare

Client Overview

A US based leading pharmaceutical company.

Business Need

  • The client wanted to develop a FDA compliance medical Infusion pump device to automate and control desired medical dosage flow rate, ensure accuracy in the amount of dosage infused into the patient’s body and reduce human errors in dosage infusion using multiple alerts and notification

VOLANSYS Contribution

  • Developed infusion pump embedded software application
  • Integrated sensors to monitor and control the flow of water/medicine fluid dosage
  • Dosage configuration for desired therapy
  • Developed GUI for 100+ screens using MICRIUM
  • Monitor battery consumption & infusion pump with audible alarms and notifications
  • Automated & Manual, Functional, Unit & System testing using Vector Cast
  • FDA class B compliance for 10,800+ line of code (LOC)
  • Code review using Crucible tool
  • ~1000 test cases to verify use cases-based functionality
  • Detect violation and fix them as per the code compliance guideline & PC Lint tool

Solution Diagram


Benefits Delivered

  • Enhanced operational accuracy and reduced errors with quality engineering and testing
  • Enabled FDA Compliance for 10K+ Line of Code
  • Intuitive GUI development for ease of use of product

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Success Stories