Cyber Security Requirements For Network Connected Medical Devices
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This information should enable product security teams to more easily find and review regulatory expectations related to medical device cybersecurity.
Cyber security requirements for network connected medical devices. Integration of advanced information technologies in medical devices has fostered the emergence of a new set of challenges for patients healthcare providers device developers and manufacturers. Anytime a medical device has software and relies on a wireless or wired connection vigilance is required. The cybersecurity response must be incorporated into the entire device lifecycle not only the design but also the development manufacturing operational maintenance and decommissioning as well. We can support you in the development of a threat model for your device or by supplementing your device risk management procedures to include risks associated with security.
Since some connected medical devices can be found on these networks they will be subject to the cybersecurity measures that manufacturers will have to implement or follow. As a consequence stringent cybersecurity measures are required on such networks. Please note many of the links below take you to a government agencies website. In this context strengthening the security of connected medical devices against cyber attacks is the responsibility of device developers and manufacturers.
We can help you identify inventory and evaluate risk controls identified in the cybersecurity risk analysis against commonly accepted risk. Medical device manufacturers mdms are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices including risks related to cybersecurity.
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