Fundamentals· Feb 24, 2024
What Is a Write Blocker? Hardware vs Software
A write blocker lets you read a drive without changing a single byte. See how hardware and software blockers differ and which one holds up as forensic evidence.
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Primer articles.
Every article in our archive tagged Primer.
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
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Showing 12 of 99 articles tagged Primer · Page 8 of 9
Risk· Feb 24, 2024
Software as a Medical Device: Definition, Risk, and Rules
Software as a medical device explained: the IMDRF definition, risk categories, FDA pathways, IEC 62304, and cybersecurity obligations under Section 524B.
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Fundamentals· Feb 23, 2024
Deciding Which Threats Are Relevant to Your Medical Device
How to decide whether a threat is relevant to your specific device using intended use, STRIDE per element, and documented reasoning a reviewer can check.
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Fundamentals· Feb 14, 2024
Recalled Medical Devices: Cyber Failures
Discover how cybersecurity failures in medical devices have led to recalls and potential risks for patients. Aligned with the FDA's Feb 3, 2026 premarket.
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Fundamentals· Feb 11, 2024
Emerging Tech and Cybersecurity Impact
Emerging technologies significantly expand the attack surface for medical devices. Learn how digital health, AI, ML, and IoT introduce vulnerabilities.
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Testing· Feb 9, 2024
SQL Injection Prevention: MedTech Security
SQL injection prevention, XSS defense, API method design, and file upload validation for medical device web software, mapped to FDA verification evidence.
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Fundamentals· Feb 2, 2024
Medical Device Cybersecurity Inventory (2026 Guide)
Medical Device Cybersecurity Inventory for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.
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Fundamentals· Feb 2, 2024
Why IDS/IPS Agents Fail on Medical Devices
Why IDS/IPS agents don’t work for medical devices and what FDA-aligned alternatives like segmentation, gateways, and monitoring mean for patient safety.
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IoT & Connected Devices· Jan 28, 2024
Connected Device Fleet Security: What Manufacturers Must Build
What medical device manufacturers must build into connected devices sold in fleet quantities: unique identity, certificate renewal, signed updates, MDS2, and FDA-ready plans.
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Fundamentals· Jan 25, 2024
Medical Device Cybersecurity: A 2026 Executive Playbook
Medical device cybersecurity for MedTech executives: what it costs, when to fund it, what Section 524B exposes you to, and what a missed postmarket plan costs.
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Fundamentals· Jan 21, 2024
MedJacking Explained: What the Term Covers and What Doesn't
What MedJacking and MedHacking actually describe, which cases are verified, and the controls that break the attack chain on fielded devices.
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Risk· Jan 19, 2024
Rising Medical Device Cyber Threats: Risks and Mitigations
In this post, we unravel this complex issue of cyber threats in medical devices and discuss what manufacturers can do to make their devices more secure.
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