Can Product-Specific Assurance Case Templates Be Used as Medical Device Standards?

International standards are a key ingredient in the quality assurance of software-intensive medical devices. One problem with such standards is that they often describe a lifecycle process that should be used to develop the system, rather than describe acceptance criteria to be applied to the system itself, thus guaranteeing safety directly in terms of the artefact's attributes. In the past few years, the U.S. Food and Drug Administration (FDA) …