A methodology for modeling and simulation of biomedical signal acquisition devices

Physicians analyze results obtained from biomedical signal acquisition devices to treat and diagnose patients with acute and chronic diseases. Therefore, results must be accurate to avoid errors during the evaluation of patients. Manufacturers should develop biomedical signal acquisition devices in order to be safe and effective. However, there are still problems related to safety and effectiveness in this type of device according to regulatory agencies such as the US Food and Drug Administration (FDA). In this context, manufacturers should use techniques to perform the formal specification, validation, and simulation to increase the dependability of devices. We propose in this paper a methodology for modeling and simulation of biomedical signal acquisition devices aiming to provide a reliable way to perform tests during its development. A case study of a non-invasive ECG device is presented as a use scenario of the methodology.