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

siteadmin March 19, 2022

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 for entities that service or remanufacture medical devices…

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