Tool and Processes for Medical Device Cybersecurity

The Food and Drug Administration (FDA) issued an updated draft of the Premarket Cybersecurity Guidance in April 2022 which, when combined with existing finalized Postmarket Management of Cybersecurity in Medical Devices Guidance, specifies process and technical requirements to ensure medical devices are “secure by design” and that their security posture can be maintained over the lifetime of the device. In this paper we propose a hypothetical medical device vendor’s mature cybersecurity program that complies with FDA guidance, and we will analyze the processes and tools that aid in their success.