Fundamentals· Mar 1, 2024
Medical Device Cybersecurity Abuse &
Medical device cybersecurity abuse and misuse leads to patient harm, operational disruption, and financial consequences. Learn how to mitigate risks.
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Field notes from the MedTech security trenches.
Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.
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Showing 12 of 292 articles · Page 19 of 25
IoT & Connected Devices· Mar 1, 2024
Differences in the IoT and the IoMT
IoT vs IoMT explained: how the Internet of Medical Things differs from consumer IoT in regulation, patient safety impact, and FDA cybersecurity expectations.
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IoT & Connected Devices· Feb 29, 2024
The Dangers of Pacemaker Hacks
Pacemaker hacks pose serious risks, potentially altering heart rhythms or causing malfunction. Learn about pacemaker security and protective measures.
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Risk· Feb 28, 2024
Bluetooth Medical Device Security: BLE Risks & FDA
Bluetooth Classic vs BLE in medical devices: BlueBorne, KNOB, spoofing, and pairing attacks - plus FDA Feb 3, 2026 expectations for encryption, authentication, and pen testing.
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Fundamentals· Feb 28, 2024
Joint Security Plan (JSP): What MedTech Teams Need to Know (2026)
Joint Security Plan (JSP) explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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Networking· Feb 27, 2024
Key Exchange in Medical Device
Learn how secure key exchange protects connected medical devices. Covers TLS, PKI, MitM/replay risks, key provisioning, rotation, and FDA-ready evidence.
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Fundamentals· Feb 27, 2024
Attack Surface Analysis for Medical Devices: 2026 Best Practices
Attack Surface Analysis for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
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FDA· Feb 25, 2024
CBER: What MedTech Teams Need to Know About FDA Biologics (2026)
CBER (Center for Biologics Evaluation and Research) explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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FDA· Feb 25, 2024
What is CDRH? FDA's Device Center Explained
The essential role of the Center for Devices and Radiological Health (CDRH) in ensuring the safety, effectiveness, and cybersecurity of medical devices.
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Fundamentals· Feb 25, 2024
UL 2900 and Medical Device Cybersecurity
UL 2900 is a critical cybersecurity standard for medical devices, recognized by the FDA. Learn how it safeguards patient data and ensures device security.
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FDA· Feb 25, 2024
SweynTooth BLE Vulnerability in Medical Devices
SweynTooth BLE Vulnerability in medical devices: attack scenarios, patient-safety impact, and mitigations FDA reviewers expect in 2026 submissions.
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FDA· Feb 25, 2024
What are Medical Device De Novo Requests?
De Novo Requests establish classifications for novel medical devices without predicates. Blue Goat Cyber helps manufacturers navigate this FDA pathway.
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