Fundamentals· May 23, 2026
When to Hire a Device Security Consultant vs. Build In-House
A decision guide for MedTech teams weighing a device security consultant against an in-house hire.
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Showing 12 of 55 articles in Fundamentals · Page 1 of 5
Fundamentals· May 22, 2026
Cybersecurity Is Now a QMS Requirement
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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Fundamentals· Apr 9, 2026
Why Medical Device Cybersecurity Is Nothing Like Enterprise
Picture a seasoned enterprise CISO handed responsibility for a fleet of connected infusion pumps and networked imaging systems.
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Fundamentals· Apr 9, 2026
How to Choose the Best Medical Device Cybersecurity Company
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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Fundamentals· Feb 16, 2026
How Can Medical Device Manufacturers Support Operational
Postmarket medical device cybersecurity is a shared responsibility. See how manufacturers & healthcare organizations must collaborate to reduce.
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Fundamentals· Dec 3, 2025
Navigating the Cybersecurity Landscape for MedTech
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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Fundamentals· Nov 30, 2025
SaMD vs SiMD: What Medical Device Manufacturers Need to Know
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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Fundamentals· Nov 30, 2025
Two Medical Device Cybersecurity Gaps
Two major medical device cybersecurity gaps - dispersed responsibility & missing asset inventories - fuel legacy and secondary-market risk.
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Fundamentals· Nov 5, 2025
What Is A Medical Cyber Device? The Med Device Cyber
Podcast recap: unpacking the FDA's medical cyber device definition - which products qualify, what §524B requires, and how to document compliance.
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Fundamentals· Nov 5, 2025
Debunking the Top 5 Medical Device Cybersecurity Myths
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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Fundamentals· Apr 13, 2025
What Are the Most Concerning Medical Device Cyber Threats?
Updated April 13, 2025 As with any connected device, cyber threats are simply part of the environment. There’s no way to remove all risk.
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Fundamentals· Nov 17, 2024
Medical Device Software Functional and Non
Dive into the intricate world of medical device software with our comprehensive guide.
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