Guides

Free Resources • Updated 2026

Medical Device Cybersecurity Guides

Practical, ungated guides for medical device manufacturers navigating FDA cybersecurity requirements - from premarket submission to postmarket operations.

Standards

The MedTech Cybersecurity Standards Decoder

FDA Section 524B, IEC 81001-5-1, AAMI SW96, ISO 14971, and more - what each standard requires, how they connect, and exactly what FDA expects to see in your submission.

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Deficiency Response

FDA Cybersecurity Deficiency Letter Response Checklist

A step-by-step 11-stage checklist for organizing and resolving an FDA cybersecurity deficiency letter for 510(k), PMA, De Novo, and HDE submissions.

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Vendor Selection

10 Reasons Medical Device Cybersecurity Vendors Fail You

Before you hire a medical device cybersecurity vendor, read this. The 10 most common ways vendors fail manufacturers - and how to spot them early.

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Pen Testing

12 Critical Findings from Medical Device Penetration Tests

What real medical device penetration tests actually find - the 12 most critical and recurring vulnerabilities, with remediation guidance for each.

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FDA Submissions

12 Reasons the FDA Rejects Medical Device Cybersecurity Submissions

The 12 most common reasons FDA sends back cybersecurity submissions, explained with specifics on what reviewers expect instead.

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Postmarket

The Postmarket Cybersecurity Readiness Plan

A three-phase, 18-step operational plan for maintaining FDA cybersecurity compliance across your device’s full postmarket lifecycle.

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SPDF

The SPDF Playbook for FDA-Ready Medical Devices

The 8-pillar Secure Product Development Framework that FDA accepts - what each pillar produces, how they connect, and a 15-point pre-submission readiness checklist.

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Threat Modeling

12 Critical Threat Modeling Gaps in Medical Device Submissions

A practical self-assessment guide to the 12 threat modeling gaps that trigger FDA cybersecurity questions, with specific fixes for each.

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