Model-based development of medical devices

Abstract

Model-based development can offer many advantages compared to other techniques. This paper will demonstrate how models are used to develop safe systems in a medical devices company. The approach described uses a combination of model-driven analysis, model-driven design, model-driven test and model-driven safety analysis. Different approaches have been developed and followed in the past. The approach presented has been developed in an evolutionary manner and by combining approaches described in literature. It turned out to be well suited for the medical device domain and is considered to be a best practice approach. As such it is part of the development process that must be followed when developing new medical devices. The development process has to be defined in a written way and is checked by TÜV and FDA auditors on a yearly base. It is considered to be well above-average and thus may be adopted by other companies developing safety-relevant devices. During the audit process it is verified that the documentation of the process is as expected and that the actual development process is performed according to the defined process. This assures for companies adopting the approach that it is authenticated by daily practice and its use requires only modest overhead. © 2009 Springer Berlin Heidelberg.