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Tag Archives: Suzanne Schwartz

DHS Helping FDA Cyber Secure Medical Devices

The Department of Homeland Security is working with the U.S. Food and Drug Administration to protect connected medical devices from emerging cyber threats, Federal News Network reported Thursday. In October, DHS began using the medical device security playbook the FDA issued to guide the government and industry in protecting such technologies.

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FDA Opens Comment Period on Medical Device Cybersecurity Guide

The Food and Drug Administration has released draft guidance to help manufacturers protect medical devices against cyber threats throughout the product lifecycle. The guide outlines postmarket strategies for the medical device industry to monitor, identify and address cybersecurity risks that could affect the performance and safety of their technology offerings, the FDA …

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FDA’s Suzanne Schwartz: Medical Device Manufacturers Need to Protect Against Cybersecurity Risks

The U.S. Food and Drug Administration recommends that cybersecurity measures become an inherent part of medical device design and development in the recently released final guidance for device manufacturers on cybersecurity risk management. “There is no such thing as a threat-proof medical device,” Suzanne Schwartz, director of emergency preparedness/operations and medical countermeasures at …

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