Regulatory Intelligence

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

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

ELTON’s Leadership and Credibility in Medical Device Cybersecurity

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

Do Legacy Medical Devices Require Ongoing Cybersecurity Monitoring and Annual Testing

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

What Happens When the FDA Flags a Cybersecurity Deficiency in Your Submission

A common question among medical device manufacturers is whether products approved before the FDA’s 2023 and upcoming 2025 Premarket Cybersecurity […]

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

What Happens When the FDA Flags a Cybersecurity Deficiency in Your Submission When a medical device submission includes cybersecurity documentation, […]

Meeting China’s CFDA Cybersecurity Law (CSL) Requirements

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

Navigating EU-MDR Recertification and MDCG Expectations

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

How ELTON Supports CAPA for Cybersecurity Vulnerabilities

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

Preparing for CVSSv4: Why Medical Device Manufacturers Must Act Now

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

FDA-Qualified CVSS Scoring: How ELTON Transforms Vulnerability Management

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

Common FDA Cybersecurity AI Deficiency Questions in Response to Submissions

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

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

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

Example SOP: Cybersecurity Risk Assessment

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

Example SOP: Postmarket Vulnerability Management

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

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

Example SOP: Vulnerability Metrics Tracking

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

Postmarket Penetration Testing: Why Every Release Needs Its Own

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

Compliance and Regulation, Penetration Testing

Why Every Release Needs Its Own Annual Penetration Test For medical device manufacturers, cybersecurity is no longer a one-time activity; […]

Understanding the FDA Secure Product Development Framework (SPDF)

Meeting Japan’s Medical Device Cybersecurity Requirements with ELTON

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

Context is the Missing Piece in Medical Device Vulnerability Management

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