Regulated Software Research Centre >> Regulated Software Research Centre (RSRC) Research

Regulated Software Research Centre (RSRC) Research

This section gives details of the research areas addressed by research performed in the Regulated Software Research Centre (RSRC).

Medical IT Networks

Medical IT Networks
The use of networked medical devices can provide a number of benefits such as improved patient safety, reduced costs of care and a reduction in adverse events. While medical devices are stringently regulated and tested, the incorporation of a medical device into an IT network can introduce additional risks, compromising the safety, effectiveness and the security of the IT network. The RSRC is performing research in the development of international standards to help address these risks.

Software Traceability

Software Traceability
Traceability is an important component in developing quality software. In addition to regulatory requirements, organisations operating within the safety critical domain must employ an effective traceability process to ensure their software is safe. However, traceability implementation is problematic as most existing software systems lack explicit traceability links between artefacts. The RSRC is performing research to develop a framework to enable the assessment of a medical device SMEs current traceability status in addition to providing a pathway for improvement.

Medical Device Software Process

Medical Device Software Process
Regulated Software Research Centre (RSRC) perform medical device software engineering research and have developed a medical device software process assessment model MDevSPICE® to reduce the overhead associated with adhering to all the medical device specific standards and regulations by bringing them together into a single model. MDevSPICE® will for the first time concentrate the accumulated medical device software best practices from all leading sources, while also supporting the industry and regulators in consistently and accurately evaluating software process implementation.

Agile Software Development

Agile Software Development
Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. The research that has been conducted in agile software development includes: • Integrating agile practices with a traditional plan-driven SDLC. • Extending the MDevSPICE® framework with agile practices to enable medical device software development to be performed in a more flexible manner. MDevSPICE® is a medical device software process assessment framework that integrates the regulatory requirements from the relevant medical device software standards.

Software Testing

Software Testing
At RSRC the research in the of the field of Software Testing focuses on the development of a testing framework for the medical device industry. The research focuses on the integration of medical device specific verification and validation practices into established testing frameworks. We look at what practices organisations having an established testing framework in place would need to implement to satisfy the verification and validation requirements as described in the medical device regulations for software. Currently, three research students working on software testing for medical device software.