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July 27, 2014
Brian Pate of SoftwareCPR® writes: In May 2014, FDA offered further guidance to manufacturers regarding premarket submission information identifying cyber-security risks and hazards associated with their medical devices, and the responsibility for engineering appropriate risk controls to address patient safety and assure proper device performance. FDA encouraged manufacturers to report any cyber-security incidents that may...
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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