Bram Schumer

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Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

9/9/2021  /  Comment Period , Cyber Attacks , Cybersecurity , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Medical Software , Public Comment , Risk Mitigation
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