FDA· Apr 9, 2026
Medical Device Cybersecurity Risk Analysis
Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act.
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Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
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Showing 12 of 19 articles tagged Risk · Page 1 of 2
Lifecycle· Apr 9, 2026
Legacy Medical Device Cybersecurity Risks in Hospitals
Legacy medical devices - Windows XP infusion pumps, unpatched imaging, flat VLANs - are the #1 hospital attack surface. Scoring, segmentation, and a 90-day fix plan.
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FDA· Feb 8, 2026
What the FDA's QMSR Means for Medical Device Cybersecurity
The QMSR replaced the Quality System Regulation with ISO 13485:2016. Learn what changed, what did not, and how cybersecurity work fits the new structure.
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FDA· Sep 29, 2025
Section 524B for MedTech Founders: A 2026 Cybersecurity Guide
What FDA Section 524B means for MedTech founders: which devices it covers, the four requirements, and how to budget for cybersecurity before your FDA submission.
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Risk· Jul 13, 2025
PATCH Act: Legacy Device Cyber Gaps
The PATCH Act became section 524B and covers new cyber devices only. See what it requires, who is exempt, and how to secure legacy medical devices.
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Risk· Nov 17, 2024
Medical Device Safety vs Security Risks
Explore the critical distinctions between safety and security risks in medical devices. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity guidance.
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Risk· Nov 2, 2024
QNX Vulnerabilities in Medical Devices
Explore QNX operating system vulnerabilities, risks, and mitigation strategies crucial for medical devices. Understand how to secure QNX-based systems.
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Risk· Oct 24, 2024
Medical Device Cybersecurity Risk Profiles (2026 Guide)
Medical Device Cybersecurity Risk Profiles for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
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Risk· Oct 22, 2024
Cellular Connectivity Device Security
Cellular connectivity medical device security: 2G/3G downgrade risk, IMSI catchers, eSIM provisioning, LTE/5G, modem data at rest, and FDA documentation.
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Risk· May 30, 2024
Medical Device Interoperability: Cybersecurity Risks Explained
Medical device interoperability creates shared risk across vendors. Learn where trust breaks down, what the FDA expects in labeling, and how to document it.
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Risk· Mar 31, 2024
IPC Vulnerabilities in Medical Devices (2026)
IPC (Inter-Process Communication) Vulnerabilities in medical devices: attack scenarios, patient-safety impact, and mitigations FDA reviewers expect in 2026 submissions.
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FDA· Mar 30, 2024
IVD Cybersecurity: Result Integrity Risk and FDA Evidence
How IVD cybersecurity differs from therapeutic devices: LIS/HL7 interfaces, analyzer OS risk, service access, QC data integrity, and submission evidence.
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