Design & Development of Automated Infusion System

Design & Development of Automated Infusion System

The Customer:

One of the largest Automated infusion system manufacturer

Problem Statement:

Infusion pump to be re-engineered for feature enhancement, bug resolution and regulatory compliance

Project Description

An infusion pump infuses fluids, medication or nutrients into a patient's circulatory system in controlled amounts. It is generally used intravenously, although subcutaneous, arterial and epidural infusions are occasionally used.

Project Scope:

  • Design as per IEC 60601-2-24 (specific to Infusion pumps)
  • Schematic and layout redesign
  • Mechanical device design and modification
  • Software development for the re-designed hardware
  • Entire product verification & validation
  • Pre-compliance testing (EMC/EMI)
  • Documentation for regulatory submission (CE Marking/ US FDA)

Business Benefit:

  • PCBs redesigned for RoHS2 compliance
  • Feature enhancement like Alarms, specific for infusion pumps (IEC 60601-2-24 & IEC 60601-1-8)
  • Feature enhancements such Device Self Test functionality, redundancy check & additional clinical modalities
  • Bug fixing for software
  • Hardware design refinement for enhanced performance and Reliability
  • Re-engineered product to ensure long product life
  • Complete documentation for regulatory submission