#510(k)

Strengthening Cybersecurity for FDA 510(k) Submissions

Robert Wilson

The landscape of medical device cybersecurity is not static. As devices become more connected and integrated into healthcare systems, the need for ongoing vigilance and post-market compliance grows in importance. For manufacturers, meeting FDA 510(k) cybersecurity requirements during the pre-market submission process is just the beginning. Ensuring that devices remain secure and compliant throughout their ... Read more

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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