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Why Medical Device Manufacturers Must Validate Their Cybersecurity Tools

ELTON

Introduction In the medical device industry, every process and every tool used in design and development must meet rigorous quality […]

Why FDA-Required Vulnerability Chaining – and How ELTON Delivers It

ELTON

Introduction In the medical device space, cybersecurity is no longer a check-the-box exercise. Connectivity, complex supply chains, and system interdependencies […]

ELTON’s Leadership and Credibility in Medical Device Cybersecurity

ELTON

For more than a decade, ELTON has been at the center of advancing medical device cybersecurity, combining technical depth, regulatory […]

When Does a Vulnerability Require Patching? Interpreting the FDA’s 2016 Postmarket Cybersecurity Guidance

Compliance and Regulation, ELTON

In the world of connected medical devices, not every vulnerability demands a patch, and not every patch is the right […]

Meeting China’s CFDA Cybersecurity Law (CSL) Requirements

Compliance and Regulation, ELTON

As the global regulatory landscape tightens around cybersecurity, medical device manufacturers looking to market in China must navigate an increasingly […]

Navigating EU-MDR Recertification and MDCG Expectations

Compliance and Regulation, ELTON

The transition to the EU Medical Device Regulation (EU-MDR) has created significant challenges for manufacturers, particularly when it comes to […]

How ELTON Supports CAPA for Cybersecurity Vulnerabilities

Compliance and Regulation, ELTON

Corrective and Preventive Action (CAPA) is a core requirement under the FDA’s Quality System Regulation, specifically 21 CFR 820.100 (Corrective […]

Preparing for CVSSv4: Why Medical Device Manufacturers Must Act Now

Compliance and Regulation, ELTON

The FDA has officially recognized CVSS v4.0 as a consensus standard for medical devices, marking a significant shift in how […]

FDA-Qualified CVSS Scoring: How ELTON Transforms Vulnerability Management

Compliance and Regulation, ELTON

FDA-Qualified CVSS Scoring: How ELTON Transforms the MITRE MDDT into Living Vulnerability Intelligence Understanding the MITRE CVSS Rubric (MDDT Q171974) […]

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

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

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 […]