Model-Based Engineering for Medical-Device Software

Model Based Requirements Engineering for Embedded Software

Software and systems development within the embedded area is dominated by model based design techniques. These techniques are commonly aligned to standard modeling languages such as UML. Along with software and systems design techniques the concern of requirements management methodologies has continuously being increased in the last years, aiming at an improvement of the overall development pro...

Trustworthy Medical Device Software

This report summarizes what the computing research community knows about the role of trustworthy software for safety and effectiveness of medical devices. Research shows that problems in medical device software result largely from a failure to apply well-known systems engineering techniques, especially during specification of requirements and analysis of human factors. Recommendations to increa...

Experiences of Engineering Grid-Based Medical Software

OBJECTIVES Grid-based technologies are emerging as potential solutions for managing and collaborating distributed resources in the biomedical domain. Few examples exist, however, of successful implementations of Grid-enabled medical systems and even fewer have been deployed for evaluation in practice. The objective of this paper is to evaluate the use in clinical practice of a Grid-based imagin...

Model-Based Software Engineering for Embedded Systems

X. Medical Device Software Traceability

Software traceability is central to medical device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements including risks through the different stages of the software development and maintenance lifecycles. The regulatory bodies reques...