Firmware testing for a class-C medical device using VectorCAST
Overview
Europe based leading technology manufacturer operating in the optics and optoelectronics industries with presence in 50+ countries and 30k+ manpower. They offer innovative solutions for industrial metrology, medical technology solutions for diagnostics and treatment in microsurgery, and microscopy solutions for the life sciences.
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Challenges
The client wanted to introduce FDA approved, class-C, microscopic medical device used for microsurgeries for healthcare domain. In order to get it approved from FDA and bring the medical device into the market, the client had to test the device using VectorCAST tool and submit the reports for the approval. For the same, the client was looking for a Quality Engineering partner with experience in the healthcare domain that would work as their extended team to test their healthcare device firmware and generate reports that shall help them achieve FDA approval
Outcomes
- Reduced compliance failure risk by testing the Source Code (C/C++) via FDA approved tool – VectorCAST
- Improved code accuracy to 90% plus with efficient testing approach
