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mgorczyca 7 min. read
The FDA Has New Requirements for Medical Device Cybersecurity and PCCPs

Here’s What You Need to Know. The U.S. Food and Drug Administration recently released draft guidance regarding artificial intelligence/machine learning-enabled medical devices. Here we take a deep dive into the legislative changes related to cybersecurity, predetermined change control plans, and the role of translation and localization services. The demand for documentation from medical device manufacturers […]

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The FDA Has New Requirements for Medical Device Cybersecurity and PCCPs
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