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Experimental evaluation of a novel ISO 14971 risk management software for medical devices

Medical devices are becoming ever more complex through constant integration of new technologies. From a regulatory perspective guaranteeing safety and low risks associated with these devices is becoming increasingly challenging for device manufacturers. This work is based on a previously developed novel software tool for risk management of medical devices. The software implements relational links among technical documents and thereby integrates sections such as system components, system requirements, product manual and others into risk management in order to increase traceability and consistency. In this paper the developed software tool was experimentally evaluated and compared to the state of the art methodology by a usability study with 14 subjects. Results show a higher mean effectivity, efficiency and subjective user satisfaction for our tool. User satisfaction could be proven to be significantly higher for our tool with a significance level of 5%.