FDA· Mar 3, 2024
VxWorks Vulnerabilities in Medical Devices
How MedTech teams should identify, triage, and document VxWorks RTOS vulnerabilities (URGENT/11 and beyond) for FDA Section 524B premarket and postmarket.
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Showing 7 of 67 articles tagged FDA · Page 6 of 6
FDA· Feb 25, 2024
SweynTooth BLE Vulnerability in Medical Devices
SweynTooth BLE Vulnerability in medical devices: attack scenarios, patient-safety impact, and mitigations the 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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FDA· Feb 25, 2024
Security Architecture Views Recommended by FDA Guidance for Submissions
FDA guidance recommends four security architecture views in a premarket submission. Learn what each one shows, how they differ, and the mistakes that draw questions.
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FDA· Jan 15, 2024
20 Common Medical Device Protocols
This post covers the purposes, security risks, & regulatory guidance for medical device protocols for manufacturers, healthcare providers, & regulatory.
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FDA· Jan 9, 2024
Attack Tree Threat Modeling for Med Devices | Blue Goat
Attack tree threat modeling explained: how it differs from STRIDE and FMEA, when to build one, and how output feeds ISO 14971 risk analysis and FDA files.
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FDA· Jan 7, 2024
JTAG UART Debug Port Security: FDA Compliance
JTAG UART debug port security guidance for medical devices: what testers find, how to lock or authenticate ports, and how to document it for the FDA.
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