Tagged · Threat Modeling

Threat Modeling articles.

Every article in our archive tagged Threat Modeling.

FDA· Sep 17, 2026

Home Use vs Hospital Device Cybersecurity Requirements

Home use vs hospital device cybersecurity: which controls the HDO environment provides, which the device must carry itself, and how the FDA reviews each case.

#FDA#Intended Use#Home Use Devices

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AI & ML· Jun 29, 2026

FDA AI Cybersecurity Threats: 7 Attacks

The FDA's Feb 3, 2026 guidance names 7 AI cyber threats, data poisoning, model inversion, evasion, leakage, overfitting, bias, drift, as 524B obligations.

#AI & ML#FDA#Section 524B

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Threat Modeling· Jun 25, 2026

TARA Threat Analysis and Risk Assessment

TARA threat analysis and risk assessment explained for medical devices, from its automotive ISO/SAE 21434 roots to mapping onto AAMI SW96 and ISO 14971.

#Threat Modeling#FDA Premarket#Risk Management

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Risk Management· Jun 25, 2026

Design FMEA for Medical Devices: dFMEA

How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand cyber failure modes to the threat model.

#dFMEA#FMEA#ISO 14971

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Risk Management· Jun 18, 2026

FMEA vs Threat Modeling for Medical Devices

FMEA covers random and systematic failure modes; threat modeling covers adversarial action.

#FMEA#Threat Modeling#ISO 14971

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Device Class· Jun 13, 2026

Infusion Pump Cybersecurity: FDA Expectations

What the FDA expects from infusion pump cybersecurity submissions in 2026: threat model focus areas, Section 524B evidence, and the deficiencies reviewers cite.

#Infusion Pumps#FDA#Section 524B

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Threat Modeling· Jun 12, 2026

Data Flow Diagrams for Medical Device Security

What a DFD is, the five DFD elements, and how data flow diagrams feed STRIDE threat modeling and the FDA's Security Architecture Views in a 2026.

#DFD#Threat Modeling#STRIDE

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Threat Modeling· May 8, 2026

Brainjacking: The Real Cyber-Physical Threat to NeuroTech

Brainjacking is unauthorized control of an implanted neurostimulator. We unpack attack vectors, clinical consequences, and what FDA reviewers expect.

#Threat Modeling

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Threat Modeling· Apr 1, 2026

Threat Modeling Connected & Implantable Devices

Medical device threat modeling steps: scoping, data flow diagrams, STRIDE, ISO 14971 harm scoring, and what FDA reviewers expect in a submission package.

#Threat Modeling

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Threat Modeling· Mar 22, 2024

DREAD vs STRIDE vs PASTA Threat Modeling

Compare STRIDE, DREAD, and PASTA threat modeling for medical devices. Learn which method is most effective and FDA-aligned for securing MedTech products.

#Threat Modeling

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FDA· Feb 25, 2024

Security Architecture Views: The FDA's Four Required Diagrams

The FDA expects four security architecture views in a premarket submission. Learn what each one shows, how they differ, and the mistakes that draw questions.

#FDA#Architecture Views#Threat Modeling

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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.

#FDA#Threat Modeling

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