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