Tagged · Primer

Primer articles.

Every article in our archive tagged Primer.

FDA· Jun 3, 2026

PMA Supplement Cybersecurity Changes

Which PMA submission type a cybersecurity change requires - 180-day supplement, Real-Time, Special, 30-day notice, or annual report - and the decision.

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FDA· Jun 3, 2026

De Novo Cybersecurity Requirements

How cybersecurity expectations apply to De Novo submissions under Section 524B - SPDF, SBOM, threat model, testing - and where De Novo differs from.

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Standards· Jun 3, 2026

IEC 81001-5-1 vs AAMI SW96 Compared

IEC 81001-5-1 vs AAMI SW96 compared side-by-side: scope, lifecycle vs risk focus, FDA recognition, and which to anchor your Secure Product Development.

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Pen Testing· Jun 1, 2026

BLE & RF Penetration Testing

What a real BLE/RF penetration test on a Class II connected medical device actually finds. Aligned with the FDA's Feb 3, 2026 premarket cybersecurity.

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Risk· Jun 1, 2026

CAN Bus Vulnerabilities in Medical Devices

Where CAN/CANopen shows up inside medical devices, the attack paths reviewers want modeled, and the controls that actually hold up under pen test.

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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.

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Standards· May 27, 2026

AAMI TIR57 vs TIR97 vs SW96

Medical device cybersecurity relies on AAMI TIR57, TIR97, and SW96. Understand their applications, FDA recognition, and how to use them for compliance.

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Pen Testing· May 27, 2026

Medical Device Penetration Testing Cost: 2026 Guide

Understand the factors influencing medical device penetration testing cost, from FDA requirements to device complexity. Get a transparent pricing breakdown.

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FDA· May 27, 2026

FDA Cybersecurity Review Timeline: 510(k) & De Novo Guide

Learn the actual timelines for FDA cybersecurity review. Understand 510(k) and De Novo clock stops, RTA hold periods, and how to avoid costly delays.

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FDA· May 23, 2026

510(k) Deficiencies That Trigger FDA Holds

The four cybersecurity deficiency patterns the FDA flags most often in 510(k) submissions - incomplete SBOMs, thin threat models, scoped-down pen tests.

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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.

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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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