Certification of Software-Driven Medical Devices

This track focuses on the issue of certification for modern medical devices. These devices rely more and more on software and are paradigmatic examples of safety critical systems. Existing approaches to software safety and certification are invariably process based; at best, this gives us only indirect, statistical evidence of safety. Thus, they do not offer the kinds of product based guarantees expected by engineers in other classical disciplines as a basis for product certification. This track focuses on the state of the art and proposals for improvement in this crucial area of research. The track includes four papers on relevant topics and a panel discussing the crucial scientific issues involved in making certification judgements.