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Readiness check
Fourteen questions, about three minutes, no account. See where your cybersecurity evidence is thin before a reviewer does.
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The medical device cybersecurity book
The full book, chapter by chapter, no signup. Architecture, threat modeling, documentation, testing, and post-market.
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Quick-start guide
Where to begin when the submission is already on the calendar and the cybersecurity file is not.
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The eight FDA cybersecurity control categories
A plain-language walk through the control categories FDA recommends, with examples and the questions QA/RA should ask.
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Reference guides: Section 524B, SBOM, threat modeling
Long-form guides with primary sources cited: FDA Section 524B requirements, FDA SBOM requirements, and STRIDE threat modeling for medical devices.
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Overview video transcript
The full text of the three-minute overview: what FDA requires for cybersecurity documentation and testing, and the five ways CyberMed helps.
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Penetration testing prep checklist
What to prepare before a medical device penetration test: scope, architecture context, access model, and the deliverables FDA-facing work needs.
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Securing the development environment
A practical checklist for AI-era development in regulated MedTech.
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Notes from submissions
Short articles on FDA cybersecurity expectations, deficiency letters, and what worked.
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Latest articles
All articles- How to Choose a Medical Device Penetration Testing Vendor
Seven questions that separate medical device penetration testing vendors from generic IT security firms, and the red flags that predict FDA deficiencies.
- What Goes in a Medical Device Penetration Test Report for FDA
The sections FDA reviewers expect in a medical device penetration test report: scope, methodology, findings with CVSS scores, anomalies, and how it ties to your risk assessment.
- How Much Does Medical Device Penetration Testing Cost?
Medical device penetration testing typically runs $15,000 to $75,000+. The drivers: interface count, device complexity, FDA reporting depth, and re-testing.