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Product Testing For A European Medical Device Manufacturer

Product Testing For A European Medical Device Manufacturer

product testing

Our client produces an advanced device tailored for individuals with Type 1 Diabetes, which monitors glucose levels and autonomously regulates insulin delivery. This intricate system comprises an insulin dispensing unit, a central control system, and a remote monitoring solution that allows physicians to review and interpret the data remotely. They have enlisted Testhouse to perform thorough testing across the entire system.

Product Testing For A European Medical Device Manufacturer

Problem Statement

  • Insufficient developer testing results in a significant increase in defect leakage during the testing phase​
  • Unclear requirements documentation leads to a high amount of rework​
  • Absence of well-defined entry and exit criteria for each phase of product development​
  • Inadequate status reporting contributes to a lack of visibility regarding the release status


  • Implement an end-to-end product testing strategy that encompasses both functional and non-functional aspects​
  • Establish testing processes by defining guidelines, templates, protocols, and criteria for each phase, including validations and tasks​
  • Established static testing framework to minimize rework and improve the overall quality of requirements​
  • Utilized model-based test design techniques to maximize test coverage efficiently​
  • Improve status reporting mechanisms to provide better visibility on the release status, by setting up real-time dashboards


  • Achieved a defect leakage rate of less than 0.5% in production​
  • Identified 25% of the total defects during the requirements phase, ensuring early detection and resolution​
  • Achieved an impressive defect acceptance rate of 98%, indicating the high quality and effectiveness of the testing process​
  • Achieved 100% test coverage, ensuring that all critical functionalities and scenarios were thoroughly tested