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

The number of recalls of medical device 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 modelbased 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 humancomputer 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 preand post-market, including their use in the wider system context. In this position paper we review our approach and the contributions to date.