Cybersecurity Insights and Perspectives from Industry Experts

Common FDA Cybersecurity AI Deficiency Questions in Response to Submissions

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

ELTON’s Subscription Penetration Testing and Platform-Based Vulnerability Management

ELTON

ELTON delivers subscription-based penetration testing integrated with its platform-driven vulnerability management solution, ensuring continuous FDA- and globally compliant cybersecurity oversight […]

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 […]

Example SOP: Cybersecurity Risk Assessment

Quality System SOPs

The following is an example of a postmarket vulnerability management SOP that aligns with global regulatory expectations. It can be […]

Example SOP: Postmarket Vulnerability Management

Quality System SOPs

The following is an example of a postmarket vulnerability management SOP that aligns with global regulatory expectations. It can be […]

Example SOP: Medical Device Cybersecurity

Quality System SOPs

The following is an example of a comprehensive cybersecurity SOP that aligns with global regulatory expectations. It can be included […]

Example SOP: Vulnerability Metrics Tracking

Quality System SOPs

The following is an example SOP that fulfills global regulatory expectations for cybersecurity vulnerability tracking. It is suitable for inclusion […]

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 […]

Context is the Missing Piece in Medical Device Vulnerability Management

ELTON

The Limits of Traditional Tools When managing vulnerabilities in complex medical devices, context is everything. Static code analysis, binary reverse […]

ELTON Vulnerability Analysis Reflects the Real-World Threat Model for Medical Devices

ELTON, Vulnerability Research

In the real world, medical devices are not attacked through perfect knowledge of the binary or direct mapping of source […]

Function-Level Reachability Sounds Great—But Falls Short in Practice

ELTON, Vulnerability Research

Function- or dependency-level reachability analysis can be incredibly powerful. When you know for certain that a vulnerable function is never […]

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 […]

Automating FDA Cybersecurity Compliance with ELTON

ELTON

Medical device manufacturers face increasing pressure to meet evolving FDA cybersecurity expectations. ELTON was designed to help companies achieve compliance […]

How ELTON Works: From Discovery to Continuous Monitoring

ELTON

At its core, ELTON is built to streamline how medical device manufacturers manage cybersecurity risk across the entire product lifecycle. […]

Why Medical Device Manufacturers Are Choosing ELTON for Vulnerability Management

ELTON

A New Era of Cybersecurity Oversight Cybersecurity for medical devices has entered a new era—one where continuous oversight is not […]

Cybersecurity Insights

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