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Carl Dumas, Software Engineering Manager, Ximedica
Ask the Engineer

Conducting Software Validation

By Carl Dumas
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Carl Dumas, Software Engineering Manager, Ximedica

Software verification and validation is a process that produces objective evidence that the software in a medical device has been thoroughly designed, tested, and meets user requirements. The level of depth of testing and documentation is based on overall risk. This installment of ‘ Ask the Engineer ’ addresses the question of when and where to start the software verification and validation process.

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