FDA· Feb 25, 2024
FDA Security Architecture Views
The FDA's four Security Architecture Views for medical devices (global system, multi-patient harm, updateability, security use cases) and how they differ.
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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 20 of 25
Fundamentals· Feb 25, 2024
QIH Medical Devices Explained
Discover the innovative world of QIH devices in medical technology. Learn about their unique features, applications, and the potential impact on patient.
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Standards· Feb 25, 2024
IEC 81001-5-1 & Medical Device Security
IEC 81001-5-1 defines requirements for integrating security into medical device software development. Learn how this standard ensures secure products.
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Fundamentals· Feb 25, 2024
Med Device Software Composition Analysis
Delve into the world of binary software composition analysis and its crucial role in medical device testing. Aligned with the FDA's Feb 3, 2026 premarket.
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Fundamentals· Feb 25, 2024
What Are IRT Medical Devices? Explained
IRT medical devices use infrared thermography to map body temperature. Learn how these devices work, their benefits, risks, and cybersecurity needs.
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Fundamentals· Feb 25, 2024
CE Marking for Medical Devices: EU MDR Guide
CE marking for medical devices under EU MDR 2017/745: what it means, how to obtain it, cybersecurity requirements, and how it differs from FDA clearance.
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IoT & Connected Devices· Feb 24, 2024
What Is DICOM in Medical Devices?
DICOM is the medical imaging standard for medical devices. Learn how it impacts interoperability, data integrity, and cybersecurity in healthcare.
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IoT & Connected Devices· Feb 24, 2024
PACS Cybersecurity: Imaging Infrastructure
PACS (Picture Archiving and Communication System) is vital for medical imaging. Learn why PACS cybersecurity is essential for safeguarding patient data.
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Fundamentals· Feb 24, 2024
What Is a Write Blocker? Hardware vs Software
What a write blocker is, how hardware and software blockers differ, and when MedTech incident response teams need one for defensible device forensics.
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Fundamentals· Feb 24, 2024
Steganography & Covert vs Overt Channels in Medical Devices
Covert channels hide data inside legitimate traffic or files; overt channels use the intended path. How steganography threatens medical device firmware, telemetry, and FDA compliance.
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Cryptography· Feb 24, 2024
Cryptographic Attacks on Medical Devices: Defense Guide (2026)
How cryptographic Attacks target medical devices, real-world examples, and the controls FDA expects manufacturers to implement in 2026.
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Fundamentals· Feb 24, 2024
What Is Software as a Medical Device?
Understand Software as a Medical Device (SaMD), its regulations, types, and impact on healthcare. Learn how SaMD aids diagnosis, treatment, and monitoring.
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