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 5 of 9
What RIS software does, RIS vs PACS vs EHR, core modules, DICOM and HL7 integration, and the security risks hospitals and device makers must plan for.
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Cellular connectivity medical device security: 2G/3G downgrade risk, IMSI catchers, eSIM provisioning, LTE/5G, modem data at rest, and FDA documentation.
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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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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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IVD Regulation Cybersecurity for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
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GMP Cybersecurity Compliance for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.
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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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Medical device interoperability creates shared risk across vendors. Learn where trust breaks down, what the FDA expects in labeling, and how to document it.
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Explore the potential vulnerabilities in MedRadio and delve into the crucial aspects of medical device cybersecurity in this insightful article.
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How Zigbee is used in medical devices, the cybersecurity risks it introduces, and controls manufacturers should build in to satisfy FDA reviewer expectations.
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BLE security for medical devices explained: pairing methods, attack classes, and what the February 3, 2026 FDA guidance expects documented.
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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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