Arguing effectiveness of biomedical signal acquisition devices using colored Petri Nets models and assurance cases in...

Reported cases of adverse events and product recalls expose limitations of biomedical signal acquisition devices. Approximately, ninety percent of the 1.210 recalls reported by the US Food and Drug Administration (FDA) between 2006 and 2011 were of class 2 devices such as Electrocardiography (ECG) devices. We show in this paper how manufacturers of biomedical signal acquisition devices can argue effectiveness of these devices using Colored Petri Nets (CPN) models and assurance cases in Goal Structuring Notation (GSN) by means of an ECG case study. We illustrate how CPN models are used to generate effectiveness evidences in order to present them during certification. In this context, we use assurance cases in GSN to present evidences arguing effectiveness of the device. We were able to conclude based on the ECG case study that the use of CPN models of devices can decrease costs and development time once manufacturers reuse them during the development and certification process.