Classification of medical software

The current state of software engineering practices in medical software development is discussed. The authors focus on patient safety (freedom from harm by a medical device) and patient vulnerability (possible indirect harm due to erroneous output). A definition of medical software which can be viewed as a three-dimensional model for medical software classification is proposed. To reduce patient vulnerability and enhance patient safety, specific points of control are derived from the model, and the implications of classification and control for medical software are discussed