Compliance and Regulation

FDA Cybersecurity Premarket Documentation: What eSTAR Requires in 2026

Compliance and Regulation

With the FDA’s final cybersecurity guidance now in full effect and the new Quality Management System Regulation (QMSR) aligned to […]

Meeting FDA Cybersecurity Guidance for Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submissions

Compliance and Regulation

The FDA’s AI Cybersecurity Requirements Go Way Beyond the On-Product Model The FDA’s January 2025 draft guidance on AI-Enabled Device […]

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

Compliance and Regulation

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?

Compliance and Regulation

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

Compliance and Regulation

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

Do Legacy Medical Devices Require Ongoing Cybersecurity Monitoring and Annual Testing

Compliance and Regulation

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

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

Compliance and Regulation

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

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) […]

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: Why Every Release Needs Its Own

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)

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 […]