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 43 articles in Fundamentals · Page 1 of 4
What is MedTech, and how does it differ from a medical device or life sciences? Clear definitions, from scalpels and sutures to connected cyber devices.
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CVSS score for medical devices: how to calculate one with a worked example, what the number means, and why the FDA doesn't treat it as a patient risk score.
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Medical device software development explained: design controls, IEC 62304 safety classes, SOUP management, verification, validation, and FDA documentation.
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You're two years into product development and still "not ready" for cybersecurity? You're already late.
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What CVSS is, how the 0-10 CVSS scale works, how 3.1 and 4.0 scoring differ, and why medical device triage adds EPSS, KEV, and patient-safety context.
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Understand whether to hire a medical device security consultant or build an in-house team. Evaluate costs, FDA expertise, and submission timelines.
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Medical device cybersecurity fundamentally differs from enterprise IT due to patient safety, FDA regulations, and unique technical constraints. Learn why.
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Choose a medical device cybersecurity provider: compare services, platforms, testing scope, submission evidence, fixed-fee terms, and support after filing.
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Postmarket device cybersecurity is a shared job. See how manufacturers and healthcare organizations collaborate to reduce risk once a device is deployed.
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Learn the difference between SaMD and SiMD, why it matters for FDA strategy, and how to build secure-by-design medical devices across your product.
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Discover the truth behind the top 5 medical device cybersecurity myths and how debunking them drives innovation, safety, and FDA compliance today.
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Discover how MedTech innovators use cybersecurity as a strategic advantage to gain investor trust, meet FDA expectations, and drive market success.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
