Mission-Critical and Safety-Critical Systems Handbook

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 ...