On-Demand Forum


Cybersecurity for Medical Devices — from Regulation to Surveillance

Robust cybersecurity for medical devices is critical for ensuring patient safety and protecting sensitive healthcare data. Healthcare organizations across the world averaged 1,463 cyberattacks per week in 2022, up 74% compared with 2021. And according to a 2022 report, 53% of digital medical devices and other internet-connected products used in hospitals had known critical vulnerabilities caused by issues including unpatched and outdated software.

Clearly, the need to harden cybersecurity is at an all-time high. The FDA agrees. Regulations from the agency applied in March 2023 require manufacturers to submit specific cybersecurity documentation with each 510(k) filing; without this, applications will not be accepted into the submission process. The FDA also outlines the expectations for device manufacturers regarding cybersecurity throughout the product life cycle, including risk management, design controls and post-market surveillance.

By downloading this online forum, you will gain a deeper understanding of the current regulatory expectations surrounding cybersecurity in medical devices.

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