Class-C Medical Device Firmware Testing using VectorCAST for a Europe-Based Healthcare Providers

Client Overview

Europe based leading technology manufacturer operating in the optics and optoelectronics industries.

Business Need

  • The client was looking for a testing partner with expertise in healthcare domain to help them get FDA approval for their class-C, microscopic medical device for microsurgeries to be launched into the market

VOLANSYS Contribution

  • Developed unit test cases & performed white box testing
  • Environment set-up in VectorCAST using tool chain
  • Design verification for each function
  • Detected logic errors & identified defects introduced by changes in code
  • Code coverage analysis/ management/ verification
  • Created compound test cases for control flow verification
  • Added user code to define custom function Input/ Output
  • Created a regression script for repeatable use (.bat, .env, .tst. files format)
  • Performed unit testing with different code coverage type: statement, branch, MC/DC
  • Test case report generation (full report, matrix report, test case management report, aggregate coverage report)

Solution Diagram


Benefits Delivered

  • Reduced compliance failure risk by testing the source code (C/C++) via FDA approved tool – VectorCAST
  • Improved medical device code accuracy to 90% plus with efficient testing approach
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