A blog about what is new (and old) in the world of active implantable medical devices 

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FDA Publishes Draft Guidance on Medical Device Cybersecurity

FDA has published a draft of the guidance document that it has developed to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions for medical devices.  This guidance document is intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and

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