Tagged · Primer

Primer articles.

Every article in our archive tagged Primer.

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.

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Standards· Jul 7, 2026

How SPDF Maps to IEC 81001-5-1 Activities

A phase-by-phase mapping of the FDA's SPDF onto IEC 81001-5-1 activities, so dual FDA + EU submissions produce one artifact set instead of two.

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Standards· Jul 7, 2026

IEC 81001-5-1 vs IEC 62304 for Medical Devices

IEC 62304 governs the software lifecycle. IEC 81001-5-1 adds security activities on top.

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Standards· Jul 7, 2026

How JSP2 and MDS2 Fit Together for Medtech

JSP2 is a development framework, MDS2 is a procurement disclosure form. Here's how the two artifacts complement each other across the device lifecycle.

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Standards· Jul 7, 2026

JSP2 vs SPDF vs IEC 81001-5-1: Framework Pick

The FDA lists JSP2, SPDF, IEC 81001-5-1, and ISA/IEC 62443-4-1 as acceptable cybersecurity frameworks. Here's how to actually pick one for your submission.

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FDA· Jul 2, 2026

Premarket FDA Cybersecurity Checklist

The premarket FDA cybersecurity submission checklist medical device teams use to pass 510(k) and PMA review under Section 524B and the 2026 guidance.

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SDLC· Jun 23, 2026

SPDF vs SSDLC: What Medtech Teams Get

SPDF vs SSDLC for medical devices. Why the FDA's Secure Product Development Framework demands more than a standard Secure SDLC, and what to add.

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FDA· Jun 10, 2026

FDA IDE Cybersecurity Requirements: 2026

What the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.

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Risk· Jun 5, 2026

MQTT Vulnerabilities in Connected

MQTT is one of the most common protocols in IoMT and one of the most commonly misconfigured.

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Pen Testing· Jun 3, 2026

Fuzz Harness Generation for Medical

How to build FDA-defensible fuzz harnesses for the protocols medical devices actually speak.

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FDA· Jun 3, 2026

SBOM Diffing & CVE Correlation Postmarket

How to operationalize SBOM diffing and CVE correlation across releases so postmarket vulnerability monitoring holds up under FDA Section 524B and the Feb.

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FDA· Jun 3, 2026

FDA Cybersecurity Major vs Minor

How the FDA distinguishes Major from Minor cybersecurity deficiencies in 510(k) and PMA reviews, the response-window difference, and how to keep findings.

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