Are the current architectural practices suitable for safety aspects of medical devices? An exploratory investigation

We have investigated approaches in the literature to assess the quality of the software architectures of medical devices, and have found evidence that there is a lack of methodologies for evaluating the software architecture design aspects of medical devices that might affect system safety. Such evidences were identified when evaluating the software architecture of the FDA Generic Infusion Pump searching for architectural evaluation approaches available in the literature. In order to fill this gap, we propose a set of quality questions that focus on analyzing software architecture design aspects of medical devices aiming safety. We show arguments on why reference projects such as the FDA Generic Infusion Pump system must satisfy our new quality questions. The quality questions were integrated into a quality model commissioned by the Brazilian Health Ministery for the certification of medical devices.