Insights

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.

AI & ML· Jan 21, 2025

AI Data Poisoning on Medical Devices: Defense Guide (2026)

How aI Data Poisoning target medical devices, real-world examples, and the controls FDA expects manufacturers to implement in 2026.

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AI & ML· Jan 21, 2025

Medical Device AI Evasion & Cybersecurity

Explore the evolving landscape of cybersecurity in healthcare as we delve into the challenges of AI model evasion and the protection of medical devices.

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AI & ML· Jan 20, 2025

AI Model Inversion Attacks on Medical Devices

How aI Model Inversion Attacks target medical devices, real-world examples, and the controls FDA expects manufacturers to implement in 2026.

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AI & ML· Jan 20, 2025

Medical Device AI Performance Drift

AI performance drift degrades medical device accuracy over time. Learn its impacts, causes, and mitigation strategies to maintain safety and efficacy.

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AI & ML· Jan 19, 2025

AI Overfitting in Medical Devices

AI overfitting in medical devices poses cybersecurity threats, leading to misdiagnosis and exploitable vulnerabilities. Learn how to mitigate these risks.

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Fundamentals· Nov 17, 2024

Functional vs Non-Functional Device Requirements

Functional vs non-functional requirements in medical device software: what each covers, how FDA reviewers evaluate them, and how cybersecurity fits in.

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FDA· Nov 17, 2024

V&V and Regression Testing for Medical

How verification, validation, and regression testing work together to produce defensible FDA premarket cybersecurity evidence under Section 524B, IEC.

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Fundamentals· Nov 17, 2024

Enhancing Medical Device Security: Tamper

Learn how tamper-proof seals and cybersecurity labeling secure medical devices, protect patient data, and support FDA compliance with Blue Goat Cyber.

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Risk· Nov 17, 2024

Medical Device Safety vs Security Risks

Explore the critical distinctions between safety and security risks in medical devices. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity guidance.

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Fundamentals· Nov 17, 2024

Traditional vs Medical Device Cybersecurity (2026)

Traditional vs Medical Device Cybersecurity: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.

#Primer

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Networking· Nov 17, 2024

Medical Device OTA Update Vulnerabilities

Explore the hidden dangers of OTA update vulnerabilities in this insightful article. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity guidance.

#Primer

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Standards· Nov 17, 2024

IEC 80001-1 Explained: Medical Device Network Risk Management

IEC 80001-1 assigns risk-management responsibilities when medical devices connect to hospital IT networks. Roles, controls, and how it maps to FDA 2026 guidance.

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