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

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

• 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

• 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)

• 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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