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Medical Device Software

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Voler wrote all the firmware and software for a heart pump. It includes screens like this, showing how to set up the system. It also includes about 100 error messages.

There are three levels of control for safety. The user interface software in the picture can fail, and the control firmware will continue to operate the pump. If the firmware were to fail, a CPLD will keep the pump running at the last set speed.

Voler did the verification testing of the software. When this class III device was submitted to the FDA they had no questions about the software. This level of success is very unusual, although we repeated it when a second version went through verification and resubmission. Again the FDA had no questions about the software.

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