The complexity of medical devices is rapidly increasing, enabled by innovations in technology. This same technology has enabled health care to expand from institutional environments to home care and mobile environments. Software plays a critical role in controlling these devices. It is essential that the dependability of these devices is assured because many of them are safety critical; i.e. can cause serious injury or death.

Modeling and simulation of device designs is emerging among medical device manufacturers as a technique to help address such challenges. Modeling and simulation has a long history of improving product quality by helping designers to detect defects that may be overlooked in a traditional software development workflow. For example, design requirements can be modeled, and then the model checked for properties of requirement consistency and completeness. Subsequently, the model can be run in-silica permitting rapid-prototyping and comprehensive real-time checking of design behavior which can ultimately...

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