Applying Thought   
About Wipro
Newsroom
Investors
Careers
  
   
Wipro Technologies Consulting IT Services Product Design Business Process Outsourcing CONTACT US
 
Case Studies
Ideas
 
Search
Medical Devices Home
Turnkey ASIC Development and Manufacturing Services
Product Realization and Regulatory Compliance
Diagnostic Imaging Solutions
Image Management Solutions
Laboratory Equipments
Medical Devices Testing
Modality Solutions
Patient Monitoring Systems
 
Global Sourcing Lounge
 
 
 
MEDICAL DEVICES
Case Study
Medical Devices
 
Independent Verification and Validation of an Infusion Pump to Obtain Regulatory Approvals
 
 
The idea
IV&V for Infusion Pump to reduce FDA approval time and decrease product time to market.
 
The client
A world leading drug delivery company
 
The business challenge
The client required independent verification and validation done for an infusion pump in reduced times. Necessary documentation to get the FDA approval for the product was a key requirement. A major imperative was to launch the product in market in the shortest time-span possible with no hurdles from the regulatory approval perspective. The client was seeking an experienced partner who had the necessary domain and functional knowledge of the product to facilitate IV&V.
 
Wipro’s solution

Wipro undertook entire responsibility for independent verification and validation for the infusion pump. The complete set up including the product was installed in Wipro lab. Testing was done with the help of test harness with additional hardware being set up for automated testing using PC. The innovative method of automated testing was done utilizing EXPECT scripting. A multiple test cases generating tool using a GUI was developed. The entirely new way of testing dramatically improved the productivity of the test team and also increased the accuracy of test cases. Testing cycle executed every fifteen days in synchronization with the feature releases from the product development team.

 
Business benefits
Reduced Time to Market
Utilizing the innovative automated testing the entire IV&V was done in reduced times to enable time to market advantage.

Regulatory Approval
Wipro facilitated the regulatory approval of the product supporting with proper documentation and submission requirement.

Decreased Cost
Employing the offshore model for IV&V the client was able to get immense cost advantage.

Support for next generation product
With in-depth understanding of the existing product, Wipro provided hardware and software solutions to the client for the next generation infusion pump.

  Send us an email
Request proposal for services
Subscribe to our monthly newsletter
  CASE STUDIES
Consulting on Bluetooth solution to remove wire clutter for an operation theatre equipment
  More case studies

 
Contact us Terms of use Privacy Sitemap