Roberto Filippini, Sara Spiller. EBG MedAustron, Austria.

Abstract:

The medical device sector is very heterogeneous and open to innovation. Without any doubt, like other industrial sectors, it is a possible target of cyberattacks, the consequences of which are potentially catastrophic. This paper presents the recent experience of a medical device manufacturer facing the challenges of analyzing, managing and maintaining cybersecurity of a complex medical device along its lifecycle. Alongside the principles that underlie the design of a secure and safe medical device, normative, technical and organizational issues have been identified and extensively discussed.