Tag Archives: software validation

Nick Recht

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht
Nick Recht

Software validation is a critical tool used to assure the quality of device software and software automated operations, including labeling. Software validation can increase the usability and reliability of the device and label, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to device manufacturers.

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Carl Dumas, Software Engineering Manager, Ximedica
Ask the Engineer

Conducting Software Validation

By Carl Dumas
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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