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5. Software Verification and Validation ... > 5.4. Traceability - Pg. 232

232 Chapter 4 5.3. System Validation (Acceptance Tests) Insofar as software validation means establishing that the software meets its requirements, software validation can be done in the laboratory. But where validation without the software qualifier means design validation--that is, showing that the product meets customer needs and is fit for its intended use--is something that must be done by the customers themselves in actual use. For medical devices, this means clinical trials or clinical evaluation. The design of clinical trials is outside the scope of this paper, and beyond my expertise as well. Medical professionals and statisticians need to be involved. A big issue in design validation is the labeling, or claims for what the device is good for. If the marketing literature makes a claim for an application of the device, the claim has to be substantiated with clinical data. Medical manufacturers cannot get away with the type of intellectual sloppiness we are used to in other types of advertising. It is insufficient to claim "new and improved"; you will have to demonstrate it. So some caution about claims is warranted. You don't have to work outside your specified range. And you also cannot control how the doctor uses the device. At least in the United States, the doctor can use devices and drugs "off-label," that is to say, contrary to the indications in the labeling that accompanies the device. But to do so is to put himself and his practice at risk, and, as a practical matter, attempting a legal defense