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.

FDA· Apr 29, 2024

FDA Medical Device Cybersecurity Labeling

FDA 2026 medical device cybersecurity labeling requirements: interfaces, SBOM, secure configuration, update/patch steps - and mistakes that cause review.

#FDA

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Risk· Apr 23, 2024

Medical Device MedRadio Vulnerabilities

Explore the potential vulnerabilities in MedRadio and delve into the crucial aspects of medical device cybersecurity in this insightful article.

#Primer

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IoT & Connected Devices· Apr 23, 2024

Zigbee in Medical Devices Cybersecurity

How Zigbee is used in medical devices, the cybersecurity risks it introduces, and controls manufacturers should build in to satisfy FDA reviewer expectations.

#Primer

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IoT & Connected Devices· Apr 21, 2024

BLE and Medical Device Cybersecurity

Explore how BLE (Bluetooth Low Energy) fortifies medical device cybersecurity. Learn about its encryption, authentication, and low-power features.

#Primer

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FDA· Apr 21, 2024

Section 524B(b)(2): Medical Device

Section 524B(b)(2) makes cybersecurity statutory for FDA cyber devices: SPDF design controls, vulnerability management, and a working patch/update mechanism.

#FDA

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Standards· Apr 21, 2024

OpenSSF for Medical Devices: 2026 Best Practices

OpenSSF for Medical Devices for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

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Risk· Apr 21, 2024

QIH Medical Device Vulnerabilities: What to Know (2026)

QIH Medical Device Vulnerabilities in medical devices: attack scenarios, patient-safety impact, and mitigations FDA reviewers expect in 2026 submissions.

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Testing· Apr 21, 2024

curl for Medical Device Cybersecurity Testing

How curl supports medical device cybersecurity testing: APIs, TLS, authentication, and update infrastructure - plus common mistakes teams should avoid.

#Testing

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Fundamentals· Apr 7, 2024

Medical Device Attack Entry Points (2026 Guide)

Medical Device Attack Entry Points in medical devices: attack scenarios, patient-safety impact, and mitigations FDA reviewers expect in 2026 submissions.

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Testing· Apr 7, 2024

Medical Device Closed Box Testing

Evaluate medical device security with closed box testing. Simulate real-world attack scenarios to identify vulnerabilities and bolster device resilience.

#Testing

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Risk· Apr 7, 2024

System-on-Chip (SoC) Vulnerabilities in Medical Devices

Learn how SoC vulnerabilities (SweynTooth, BrakTooth, NUCLEAUS) threaten connected medical devices-and what manufacturers need to secure and comply.

#Primer

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Risk· Apr 7, 2024

Key Escrow for Medical Devices: 2026 Best Practices

Key Escrow for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

#Primer#Risk

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