Regulatory Intelligence

“We Did a Pentest” No Longer Satisfies Medical Device Regulators

The FDA’s AI Cybersecurity Requirements Go Way Beyond the On-Product Model The FDA’s January 2025 draft guidance on AI-Enabled Device […]

Understanding Is Predictability: A Better Model for Vulnerability Management

Introduction For more than a decade, we have had a singular focus on cybersecurity testing of medical device targets. During […]

QMSR: FDA Replaced 21 CFR Part 820 with ISO 13485:2016 – What does this mean for cybersecurity?

The question is no longer, “Do you know every vulnerability in your product?” It is, “If one appeared tomorrow in […]

How ELTON Helps Manufacturers Avoid Unnecessary Fixes, Recalls, and Fire Drills

This week marks a significant milestone in medical device regulation. The FDA’s Quality Management System Regulation (QMSR) officially took effect […]

The Hidden Complexity of FDA Cybersecurity: Why Every Product Release Is Its Own Lifecycle

In medical device cybersecurity, the most expensive mistake is not missing a vulnerability. It is fixing the wrong one. Manufacturers […]

Case Study: Responding to FDA Addition Information (AI) Requests

For medical device manufacturers, cybersecurity compliance is no longer scoped at the product level. Under modern FDA expectations, every commercial […]

Case Study

Background A late-stage medical device manufacturer faced a major regulatory setback after the FDA questioned their premarket cybersecurity submission. Their […]

Why Medical Device Manufacturers Must Validate Their Cybersecurity Tools

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, Penetration Testing

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

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 […]