Tagged · Threat Modeling

Threat Modeling articles.

Every article in our archive tagged Threat Modeling.

Threat Modeling· Jun 25, 2026

TARA for Medical Devices: FDA Premarket Threat Analysis

How Threat Analysis and Risk Assessment (TARA) fits FDA premarket cybersecurity, AAMI TIR57, 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, ISO 14971 & Cybersecurity

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

#dFMEA#FMEA#ISO 14971

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Risk Management· Jun 18, 2026

FMEA vs Threat Modeling for Medical Devices: Where Safety Risk Ends and Security Risk Begins

FMEA covers random and systematic failure modes; threat modeling covers adversarial action. Both are required for a §524B submission, and they do not substitute for each other. Here is how to scope them, link them, and avoid the gap.

#FMEA#Threat Modeling#ISO 14971

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Device Class· Jun 13, 2026

Infusion Pump Cybersecurity: FDA Expectations in 2026

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

#Infusion Pumps#FDA#Section 524B

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Threat Modeling· Jun 12, 2026

Data Flow Diagrams for Medical Device Cybersecurity

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 submission.

#DFD#Threat Modeling#STRIDE

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Penetration Testing· Jun 11, 2026

Penetration Test Case Design for Medical Devices

How to design penetration test cases from a medical device threat model, the methodology that bridges STRIDE-style threats and concrete bench test execution, with traceability the FDA expects in Slot 7.

#Penetration Testing#Threat Modeling#eSTAR

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Threat Modeling· May 8, 2026

Brainjacking: The Real Cyber-Physical Threat to NeuroTech

Brainjacking is the unauthorized control of an implanted neurostimulator. We unpack the attack vectors, clinical consequences, and what manufacturers.

#Threat Modeling

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Threat Modeling· Apr 10, 2026

Threat Modeling Connected & Implantable Devices

If you're asking how to conduct a cybersecurity threat model for a connected or implantable medical device, the first thing to understand is that this is.

#Threat Modeling#IoT

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Threat Modeling· Mar 22, 2024

DREAD vs STRIDE vs PASTA Threat Modeling for Medical Devices

STRIDE is the preferred threat modeling baseline for medical device cybersecurity. Compare STRIDE, DREAD, and PASTA and when to use each.\

#Threat Modeling

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FDA· Feb 25, 2024

FDA Security Architecture Views for Medical Devices

The FDA's four Security Architecture Views for medical devices (global system, multi-patient harm, updateability, security use cases) and how they differ from a DFD.

#FDA#Architecture Views#Threat Modeling

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FDA· Jan 9, 2024

Medical Device Threat and Attack Trees

In this post, we explore the differences and similarities between threat trees and attack trees, specifically in the context of medical device FDA.

#FDA#Threat Modeling

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