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MDT: Testing Error Conditions in Control Software for a Heart Pump

Medical Design Technology (MDT)

In a recent medical device project, we designed the control software and wrote the verification protocol for a class III heart pump. Our client submitted to the FDA and we are very happy to say that it was approved without any conditions or comments. It was quite unusual that the FDA had no comments on software. Normally, when you do an FDA submission on any device that has software, most of the issues are around software. In our case, they didn’t have any!

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