Ensures medical device software is developed safely
For over two thousand years, ‘first, do no harm’ has been a central pillar of medicine. However, patient safety and the avoidance of harm don’t only apply to the medical profession. Patient safety and quality is also of paramount importance to manufacturers of the medical devices that doctors, nurses, and hospital technicians use to save peoples’ lives. Many of these devices, such as MRI and CT scanners, patient monitors, cardiac pacemakers, and myriad other electronic medical devices are software driven and safety critical.
While the compiler is typically not part of a medical device’s embedded software, it is an essential part of the tool chain used by application developers to produce the code that goes into a device. For safety-critical applications, an assumption that the compiler perfectly translates the source code is not enough. Compiler verification is needed to provide evidence that the compiled code correctly implements the source code in the target use case. Few if any compilers are free of bugs, so application developers need to discover and document bugs so they can avoid them.
Our SuperTest Compiler Test and Validation Suite for C and C++ compilers can be easily configured for any specific use case, including specific compiler option settings and optimization levels. Equally important, it provides traceability from individual verification tests to the C and C++ language standards, helping to ensure that the requirements stated in the language standards are covered by tests vice versa.
The open-source C and C++ standard libraries often used in software development projects are regarded by IEC 62304 as ‘Software of Unknown Provenance’ (SOUP) – software components used in a medical device that were not developed according to the standard’s software lifecycle processes. The standard therefore requires medical device manufacturers to assess the risks, implement control measures, and justify the suitability of these SOUP components to ensure patient safety. It makes library qualification essential.
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