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