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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Showing 12 of 44 articles in Fundamentals · Page 2 of 4
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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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.
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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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Fundamentals· Nov 2, 2024
Therac-25 Case Study: Race Condition, Deaths and Lessons
Therac-25 case study: how a race condition and removed interlocks caused six overdoses and three deaths (1985-87), and what it taught device makers.
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Fundamentals· Sep 18, 2024
Code and Data Integrity Controls for Medical Devices
Code and data integrity controls explained: signed firmware, secure boot, anti-rollback, and the evidence the FDA expects for each in premarket review.
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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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Fundamentals· Apr 7, 2024
SoC Security in Medical Devices: Reducing Attack Surface
SoC security medical devices guidance: secure boot, debug interfaces, SBOM coverage, and FDA documentation for silicon-level cybersecurity risk.
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Fundamentals· Mar 21, 2024
Cybersecurity Neglect in MedTech: The Real Threat
Cybersecurity Neglect in MedTech: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.
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Fundamentals· Mar 3, 2024
CIA Triad vs NSA Controls in Medical Devices
Explore how the CIA Triad and NSA cybersecurity controls strengthen medical device security and support FDA compliance from design to postmarket.
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Fundamentals· Mar 1, 2024
Microkernel Architectures for Medical Devices
Microkernels can improve isolation and reduce trusted code in medical devices. Learn real tradeoffs, design patterns, and FDA-friendly evidence ideas.
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Fundamentals· Mar 1, 2024
Medical Device Cybersecurity Abuse and Misuse: Impact and Risks
Medical device cybersecurity abuse and misuse leads to patient harm, operational disruption, and financial consequences. Learn how to mitigate risks.
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