#510(k)

Navigating FDA 510(k) Cybersecurity Controls for Medical Devices

Robert Wilson

The medical device industry is evolving rapidly, with new innovations transforming patient care and treatment. However, as these devices become increasingly connected and reliant on software, they also become targets for cyber threats. To address these concerns, the U.S. Food and Drug Administration (FDA) has established rigorous cybersecurity requirements as part of its 510(k) premarket ... Read more

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