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Medical Device Safety and Security: Obvious but not easy to achieve

March 25, 2020

With accelerating technology innovation, medical devices are becoming more sophisticated and more connected. Consequently, as in most mission-critical systems, safety and security are two increasingly vital requirements in medical device design. The U.S. Food & Drug Administration (FDA) announced plans to increase regulatory powers over medical device safety, including cybersecurity. This paper will explore challenges around safety and security requirements related to medical devices, as well as specific measures to deal with these challenges.

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