FDA Finalizes Medical Device Cybersecurity Premarket Guidance
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
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Search Results for: medical device cybersecurity
Top Experts Discuss Medical Device Cybersecurity Standards
Four medical device cybersecurity experts—Leon Lerman, CEO and co-founder of Cynerio; Scott Trevino, senior vice president of cybersecurity at TRIMEDX; Shankar Somasundaram, CEO of Asimily; and Ty Greenhalgh, industry principal of healthcare at Claroty—discuss how their platforms comply with various frameworks, offering real-time monitoring, encryption, and incident response to protect medical devices from emerging threats.
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Blue Goat Cyber Expands Medical Device Cybersecurity Services
Blue Goat Cyber expanded its pre- and post-market cybersecurity services for medical devices, helping manufacturers navigate FDA regulations.
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FDA Tightens Medical Device Cybersecurity Regulations
The FDA now mandates that medical device manufacturers include a Software Bill of Materials for cybersecurity compliance under the FD&C Act.
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FDA Issues Final Guidance for Medical Device Cybersecurity
The FDA has released final guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” which offers recommendations on medical device cybersecurity and the information to include in premarket submissions.
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