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.
Showing 12 of 99 articles tagged Primer · Page 7 of 9
Medical device cybersecurity abuse and misuse leads to patient harm, operational disruption, and financial consequences. Learn how to mitigate risks.
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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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CBER (Center for Biologics Evaluation and Research) explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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The essential role of the Center for Devices and Radiological Health (CDRH) in ensuring the safety, effectiveness, and cybersecurity of medical devices.
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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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FDA product code QIH covers automated radiological image processing software. Learn its classification, cybersecurity risks, Section 524B duties, and AI change controls.
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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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DICOM is the medical imaging standard for medical devices. Learn how it impacts interoperability, data integrity, and cybersecurity in healthcare.
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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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