Tagged · Primer

Primer articles.

Every article in our archive tagged Primer.

FDA· May 22, 2026

Q-Day: A Present-Day FDA Compliance Gap

The FDA's February 2026 premarket guidance requires cryptography that stays strong throughout a device's service life. Q-Day exposes a real compliance gap.

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FDA· May 22, 2026

FDA 483 Cybersecurity Observations on QMSR

How the FDA is using Form 483 observations to cite cybersecurity gaps under QMSR and 21 CFR 820, with recent examples and how manufacturers should respond.

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SBOM & Supply Chain· May 17, 2026

SBOM vs VEX: What's the Difference?

SBOM vs VEX explained for medical device submissions. What each document does, how they pair, and what the FDA actually expects in your 510(k) package.

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FDA· May 17, 2026

5 VEX Mistakes That Trigger FDA Findings

Avoid common VEX mistakes that trigger FDA cybersecurity deficiencies. Learn to properly prepare your VEX for medical device premarket submissions.

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FDA· May 17, 2026

FDA Deficiency Letter vs RTA vs Hold

FDA Deficiency Letter, RTA, and Hold Letter explained side-by-side. What each one means, the clock impact, and how to respond without losing months.

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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· 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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Risk· Jan 25, 2026

NeuroTech Cybersecurity Risks

NeuroTech cybersecurity risks affect therapy and neural data. Learn threats, controls, and FDA-ready documentation for neurostimulators, EEG, and BCI.

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Standards· Dec 4, 2025

Medical Device Cybersecurity Labeling

Learn how to get medical device cybersecurity labeling right with MDS2, JSP2, and FDA expectations - improving transparency, accountability, and patient.

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Strategy· Dec 3, 2025

Market Intelligence & Cybersecurity for MedTech

How MedTech teams combine market intelligence and cybersecurity to accelerate growth, de-risk FDA submissions, and win enterprise health-system deals.

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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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