Every article in our archive in Fundamentals.
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.
Showing 12 of 44 articles in Fundamentals · Page 3 of 4
Joint Security Plan (JSP) explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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A working method for enumerating a medical device attack surface by interface class, mapping it to threat models and test scope, and the interfaces teams forget.
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UL 2900 is a critical cybersecurity standard for medical devices, recognized by the FDA. Learn how it safeguards patient data and ensures device security.
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Discover the innovative world of QIH devices in medical technology. Learn about their unique features, applications, and the potential impact on patient.
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Delve into the world of binary software composition analysis and its crucial role in medical device testing. Aligned with the FDA's Feb 3, 2026 premarket.
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IRT medical devices use infrared thermography to map body temperature. Learn how these devices work, their benefits, risks, and cybersecurity needs.
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CE marking medical devices under EU MDR 2017/745 and IVDR 2017/746: classification, conformity routes, technical documentation, and cybersecurity evidence.
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PACS is the imaging archive that stores and moves DICOM studies. Learn how PACS is regulated, where it is exposed, and what the FDA expects you to document.
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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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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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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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Emerging technologies significantly expand the attack surface for medical devices. Learn how digital health, AI, ML, and IoT introduce vulnerabilities.
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