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.

Lifecycle· Nov 17, 2024

Secure Updates for Medical Devices: 2026 Best Practices

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

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IoT & Connected Devices· Nov 16, 2024

Embedded Cybersecurity Challenges MedTech

The embedded-systems cybersecurity challenges that derail FDA premarket submissions - from constrained crypto to firmware update integrity - and how to fix.

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Fundamentals· Nov 16, 2024

Manufacturer Cybersecurity Checklist (2026)

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

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FDA· Nov 13, 2024

RTOS Cybersecurity for Medical Devices

How to secure real-time operating systems (FreeRTOS, VxWorks, QNX, Zephyr) inside medical devices and evidence the controls in a §524B premarket.

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FDA· Nov 10, 2024

Modular PMA Submission: What MedTech Teams Need to Know (2026)

Modular PMA Submission explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.

#FDA#Premarket

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Fundamentals· Nov 2, 2024

AR Medical Device Cybersecurity Risks (2026)

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

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Risk· Nov 2, 2024

QNX Vulnerabilities in Medical Devices

Explore QNX operating system vulnerabilities, risks, and mitigation strategies crucial for medical devices. Understand how to secure QNX-based systems.

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Fundamentals· Nov 2, 2024

Therac-25: What Happened, Root Cause & Lessons for MedTech

The Therac-25 killed and injured patients between 1985-1987 due to a software race condition and removed hardware interlocks. Root cause, timeline, and modern lessons.

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Pen Testing· Nov 2, 2024

Medical Device Robustnesss & Fuzz Testing

Ensure medical device safety with robustness and fuzz testing. Uncover critical vulnerabilities and maintain performance under diverse conditions.

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Testing· Nov 2, 2024

Medical Device Abuse & Misuse Testing

Abuse and misuse case testing for medical devices: how to design malformed and unexpected input tests that surface real safety risks before FDA submission.

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Standards· Oct 28, 2024

MDCG 2019-16 & MedTech Cybersecurity

Explore the implications of MDCG 2019-16 on medical device cybersecurity, highlighting key guidelines, industry challenges, and strategies for ensuring.

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IoT & Connected Devices· Oct 27, 2024

What Is a Radiology Information System?

RIS meaning explained: what RIS software does, how RIS integrates with PACS/EHR using HL7 and DICOM, and key cybersecurity controls to reduce risk.

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