High-Confidence Medical Device Software Development

High-Confidence Medical Device Software Development

The design of bug-free and safe medical device software is challenging, especially in complex implantable devices. This is due to the device's closed-loop interaction with the patient's organs, which are stochastic physical environments. The life-critical nature and the lack of existing industry standards to enforce software validation make this an ideal domain for exploring design automation c...

Towards high confidence medical device software

COVER FEATURE High-Confidence Medical Device Software and Systems

The United States spends about 16 percent of its gross domestic product on healthcare, twice the average of most European nations. Given the shortage of caregivers and the growth of an aging US population, the future of US healthcare quality does not look promising and definitely does not look cheaper. Advances in health information systems and healthcare technology offer a tremendous opportuni...

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...

Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device and should be dev...