Authors
Robert Schmitt

Abstract

All major trends in MedTech have one thing in common: medical devices are going to be more complex than ever - and so are the networks they belong to. A necessary measure to cope with this and other emerging challenges is a satisfactory risk management process. Today, manufacturers address safety hazards with a multitude of techniques, all of which are document-based approaches.
This paper presents research on how applying model-based risk management could eliminate disadvantages that are endemic to existing methods, like uncertainty of coverage, incompatibility of professional mind-sets or typical bias-bydesign flaws. Risk management, based on a structured, computerised model of
both the physical product and its lifecycle, has the potential to improve processing in all stages. We explain how our concepts allow for comprehensive risk identification, interconnected expert judgements and standardisable classification for better risk evaluation; they also help enforcing risk treatment by reducing process cost.