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Showing 12 of 120 articles tagged Primer · Page 5 of 10

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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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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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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Risk· Oct 22, 2024

GSM Cybersecurity Risks for Medical

Medical devices using GSM face downgrade and interception risks. Learn practical mitigations: disable 2G, use TLS/mTLS, secure APNs, and FDA-ready.

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IoT & Connected Devices· Oct 22, 2024

NFC and Medical Device Cybersecurity

Discover the critical role of Near Field Communication (NFC) in safeguarding medical devices from cyber threats. Aligned with the FDA's Feb 3, 2026 premarket.

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Risk· Oct 22, 2024

M2M Communication Vulnerabilities in Medical Devices

The risks and vulnerabilities in M2M communication between connected medical devices, and the cybersecurity controls the FDA expects at premarket review.

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