Tagged · Threat Modeling

Threat Modeling articles.

Every article in our archive tagged Threat Modeling.

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 for Medical Devices: FDA Premarket

How Threat Analysis and Risk Assessment (TARA) fits FDA premarket cybersecurity, AAMI TIR57 / ANSI/AAMI SW96:2023, and ISO 14971 for medical device manufacturers in 2026.

#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

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

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

#Infusion Pumps#FDA#Section 524B

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Threat Modeling· Jun 12, 2026

Data Flow Diagrams for Medical Device

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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Penetration Testing· Jun 11, 2026

Penetration Test Case Design for Medical

How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test.

#Penetration Testing#Threat Modeling#eSTAR

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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

A short orientation to threat modeling connected and implantable medical devices, with a pointer to the full STRIDE pillar guide for FDA-ready methodology.

#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

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.

#FDA#Architecture Views#Threat Modeling

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FDA· Jan 9, 2024

Threat Trees vs Attack Trees for Medical Devices

Threat Trees vs Attack Trees for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

#FDA#Threat Modeling

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