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) introduced a (strong) recommendation that manufacturers submit an assurance case in their submission for approval to market an infusion pump. This reflects a move toward a more product/evidence-based approach to certification, compared with the primarily process-based certification used in the past. The perceived advantage of an assurance case is that it obliges the manufacturer to make an explicit argument regarding the safety/security/reliability of their product, under expected operating conditions. Taking this idea one step further, we explore whether there are benefits to using an assurance case Template as a new kind of standard, replacing existing process standards, and we describe some benefits of doing this. Editor's notes: The traditional approach for device approval by the U.S. Food and Drug Administration (FDA) has been to review the lifecycle process that has been used to develop the device, rather than describe acceptance criteria to be applied to the system itself, thus guaranteeing safety directly in terms of the artifacts attributes. Recently, the FDA introduced a strong recommendation that manufacturers submit an assurance case in their submission for approval to market use a product domain assurance case template as a standard for the development and licensing of medical devices within that product domain. This paper proposes that device developers use a product domain assurance case template as a standard for the development and licensing of medical devices within that product domain. The assurance case template approach includes a complete, documented argument, examples of evidence, and associated acceptance criteria that must accompany the case. The paper argues that the use of approved device/domain-specific assurance case templates provides the necessary confidence and insight into the device';s safety and efficacy. Rahul Mangharam, University of Pennsylvania