Software-based medical devices need to be maintained throughout their entire life cycle. The efficiency of after-sales maintenance can be improved by managing medical systems remotely. This paper presents how to design the remote access function extensions in order to prevent risks imposed by uncontrolled remote access. A thorough analysis of standards and legislation requirements regarding safe operation and risk management of medical devices is presented. Based on the formal requirements, a multi-layer machine design solution is proposed that eliminates remote connectivity risks by strict separation of regular device functionalities from remote management service, deploys encrypted communication links and uses digital signatures to prevent mishandling of software images. The proposed system may also be used as an efficient version update of the existing medical device designs.
Keywords: PEMS; medical devices; programmable electrical medical systems; remote management; risk management.