Every article in our archive in Fundamentals.
Showing 12 of 58 articles in Fundamentals · Page 1 of 5
You're two years into product development and still "not ready" for cybersecurity? You're already late. When to start medical device cybersecurity, by phase.
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Choosing between MedCrypt, Finite State, and Blue Goat Cyber? Compare SBOM tools, vulnerability management, and FDA-required pen testing for your medical device
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CVSS 3.1 vs 4.0 for medical devices compared - vector strings explained metric by metric, why 4.0's Safety and Automatable metrics matter for patient harm, and how to handle the transition in FDA submissions and postmarket VEX.
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A decision guide for MedTech teams weighing a device security consultant against an in-house hire.
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Cybersecurity documentation belongs in the QMS, not a side folder. What MedTech teams must create, control, and maintain across the full device lifecycle.
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Picture a seasoned enterprise CISO handed responsibility for a fleet of connected infusion pumps and networked imaging systems.
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Many MedTech companies end up with the wrong cybersecurity vendor. Not because they don't care about security, and not because good options don't exist.
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Postmarket medical device cybersecurity is a shared responsibility. See how manufacturers & healthcare organizations must collaborate to reduce.
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Learn how ISO 13485, robust QMS, and strong cybersecurity help MedTech innovators avoid FDA rejections, navigate HIPAA vs FDA, and secure SAMD/SIMD.
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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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Two major medical device cybersecurity gaps - dispersed responsibility & missing asset inventories - fuel legacy and secondary-market risk.
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Discover the truth behind the top 5 medical device cybersecurity myths and learn how debunking them can drive innovation, safety, and compliance in.
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