Compliance and Regulation

Common FDA Cybersecurity AI Deficiency Questions in Response to Submissions

Compliance and Regulation

FDA Submission AI Questions The FDA’s 2023 and 2025 cybersecurity guidance highlight recurring deficiencies, including missing threat models, inadequate testing […]

How ELTON Protects from FDA Cybersecurity Audits

Compliance and Regulation

The FDA’s cybersecurity guidance demands continuous oversight, documented processes, and defensible vulnerability management across the medical device lifecycle. Many manufacturers […]

Postmarket Penetration Testing is Standard for Medical Device Cybersecurity Compliance

Compliance and Regulation, Penetration Testing

For medical device manufacturers, cybersecurity is no longer a one-time activity—it is a regulated, continuous obligation. One of the clearest […]

Understanding the FDA Secure Product Development Framework (SPDF)

Compliance and Regulation

The FDA’s 2023 and 2025 Premarket Cybersecurity Guidance introduced the Secure Product Development Framework (SPDF) as a cornerstone expectation for […]

Meeting Japan’s Medical Device Cybersecurity Requirements with ELTON

Compliance and Regulation

Japan has adopted two key standards that shape how medical device manufacturers must design, build, and maintain safe and secure […]

Meeting FDA Vulnerability Metrics with ELTON

Compliance and Regulation, ELTON, Vulnerability Management

As of 2025, regardless of Cyber Device classification, as part of your FDA premarket submission, you submitted a Vulnerability Management […]

FDA Cybersecurity Guidance Update: What 2025 Changes Mean for Medical Device Manufacturers

Compliance and Regulation, Cybersecurity Trends and Insights, ELTON, Vulnerability Management

The FDA released an updated version of its premarket cybersecurity guidance on June 27, 2025, its first revision since the […]