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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Showing 12 of 29 articles tagged Risk · Page 1 of 3
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
A New Era for Quality and Safety
How the FDA's QMSR incorporates ISO 13485:2016 and aligns with Section 524B cybersecurity expectations for medical device manufacturers.
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Risk· Jan 25, 2026
NeuroTech Cybersecurity Risks
NeuroTech cybersecurity risks affect therapy and neural data. Learn threats, controls, and FDA-ready documentation for neurostimulators, EEG, and BCI.
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Strategy· Sep 29, 2025
Founder Guide to MedTech Cyber Risk (2026)
Cybersecurity is the overlooked threat in MedTech. Discover how Blue Goat Cyber helps founders avoid FDA delays, protect patients, and win investor trust.
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Risk· Sep 29, 2025
MedTech Cybersecurity Leadership: A 2026 Playbook
MedTech Cybersecurity Leadership: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
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Risk· Jul 13, 2025
PATCH Act & Legacy Medical Devices
The PATCH Act only applies to new medical devices. Legacy medical devices pose significant cybersecurity risks because they lack modern protections.
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Risk· Jul 13, 2025
Ventilator Cybersecurity Recall: Lessons for MedTech
Ventilator Cybersecurity Recall Lessons: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
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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
GSM Cybersecurity Risks for Medical
Medical devices using GSM face downgrade and interception risks. Learn practical mitigations: disable 2G, use TLS/mTLS, secure APNs, and FDA-ready.
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