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

The FDA has increased its focus on mitigating cybersecurity risks in medical device software. In June, it issued two documents that are important not only for entities that service or remanufacture medical devices, but also original manufacturers: guidance distinguishing “remanufacturing” and “servicing” a medical device, and a paper on the challenges and opportunities in addressing […]
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