This document discusses model-based engineering approaches used by Siemens Healthcare in developing medical device software. It identifies challenges such as ambiguous specifications, complex architectures, and lack of verification and validation efficiency. Siemens addresses these issues through solutions like a requirements engineering meta-model to provide structure and traceability between business needs and technical specifications. They also use feature models and graphical clinical workflow models to improve understanding, scoping, and impact analysis for large projects. The aim is to increase efficiency, quality and productivity in medical device development.