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Showing 12 of 55 articles in Fundamentals · Page 1 of 5

Fundamentals· Jul 7, 2026

When to Start Medical Device Cybersecurity

You're two years into product development and still "not ready" for cybersecurity? You're already late.

#Primer

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Fundamentals· Jun 1, 2026

CVSS 3.1 vs 4.0 for Medical Devices: Safety & Automatable Metrics

Why CVSS 4.0's Safety and Automatable metrics matter for patient harm, and how to handle the transition in FDA submissions and postmarket VEX statements.

#Primer

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Fundamentals· May 23, 2026

Hire Cybersecurity Consultant vs. In-House

Understand whether to hire a medical device security consultant or build an in-house team. Evaluate costs, FDA expertise, and submission timelines.

#Primer

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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

Medical device cybersecurity fundamentally differs from enterprise IT due to patient safety, FDA regulations, and unique technical constraints. Learn why.

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Fundamentals· Apr 9, 2026

How to Choose a Medical Device

Medical device cybersecurity company selection: 5 criteria that separate FDA-fluent specialists from generalists, with the questions that surface real depth.

#Best Practices

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Fundamentals· Feb 16, 2026

How Can Medical Device Manufacturers

Postmarket medical device cybersecurity is a shared responsibility. See how manufacturers & healthcare organizations must collaborate to reduce. Aligned with.

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Fundamentals· Dec 3, 2025

MedTech Cybersecurity Insights: A 2026 Playbook

MedTech Cybersecurity Insights for Innovators: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.

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Fundamentals· Nov 30, 2025

SaMD vs SiMD: What 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

Ownership and Asset Inventory Gaps in MedTech

Ownership & Asset Inventory Gaps: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.

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