Human-Computer Interaction and the Formal Certification and Assurance of Medical Devices: The CHI+MED Project

ABSTRACT. The number of recalls of medical devices with embedded computers due to safety issues in recent years suggests there is a need for new approaches to support the process. There is increasing concern about the impact of systematic use errors. There has been little research focusing on model-based tool support for the assurance and certification of medical devices with respect to systematic use error, however. The CHI+MED project (http://www.chi-med.ac.uk) aims to address this gap. It is concerned with the design of safer medical devices with a specific focus on human-computer interaction. We are developing a range of integrated model-based engineering methods and other formal and semi-formal techniques to support the certification process, both pre- and post-market, including their use in the wider system context. In this position paper we review our approach and the contributions to date.