Software validation of medical instruments

Software validation is a critical issue in several applications. For medical instruments, an ineffective validation may result in human injuries and death. We consider the problem of analyzing software embedded in these medical instruments, correlating with other instruments of the Legal Metrology and Conformity Assessment, such as smart meters or employee payroll recorders. In such cases, an effective way to guarantee an appropriate behavior of an instrument is to conduct a complete validation of its software and hardware - including the source-code and hardware topology details. In the present work, we describe an approach that reduces the amount of intellectual property released to the regulator, protecting the manufacturer´s intellectual property, and at the same time it provides traceability and correctness of the measurements.