One hub per topic. Grouped by where you are in the journey.
Each hub aggregates our services, in-depth guides, standards reference, blog posts, and FAQs for a single MedTech cybersecurity entity. Together they map every step from concept design through postmarket response.
Stage 1
Design & Develop
Build the cybersecurity evidence into the product, not on top of it. These hubs cover the standards, threat-modeling, SBOM, and SaMD-specific work that has to happen before a submission is even drafted.
4 hubs
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MedTech Cybersecurity Standards
FDA guidance, AAMI, ISO, IEC, and NIST standards that govern medical device cybersecurity - what each one requires and how they connect.
- 4
- services
- 2
- guides
- 3
- posts
- 12
- standards
Featured guideThe MedTech Cybersecurity Standards Decoder
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Software as a Medical Device (SaMD) Cybersecurity
Cybersecurity for Software as a Medical Device (SaMD) - cloud, mobile, and standalone software under FDA 2026 guidance, IEC 62304/81001-5-1, and Section 524B.
- 5
- services
- 4
- guides
- 4
- posts
- 6
- standards
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Threat Modeling for Medical Devices
Threat models that hold up under FDA review - STRIDE applied to connected and implantable devices, AAMI SW96 alignment, and the gaps reviewers flag most often.
- 3
- services
- 2
- guides
- 3
- posts
- 5
- standards
Featured guide12 Critical Threat-Modeling Gaps in Submissions
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SBOMs for Medical Devices
FDA-compliant SBOM generation, CVE/KEV monitoring, and the formats (SPDX, CycloneDX) reviewers expect in 510(k), De Novo, PMA, and IDE submissions.
- 3
- services
- 2
- guides
- 1
- posts
- 4
- standards
Featured guideThe MedTech Cybersecurity Standards Decoder
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Stage 2
Submit & Clear
Get through FDA premarket review on the first attempt. These hubs cover the seven-section eSTAR cybersecurity package, pathway-specific differences, and the penetration-testing evidence reviewers expect.
4 hubs
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FDA Premarket Cybersecurity
Everything a MedTech team needs to clear FDA premarket cybersecurity review under Feb 2026 guidance and Section 524B - services, guides, FAQs.
- 4
- services
- 4
- guides
- 3
- posts
- 5
- standards
Featured guide12 Reasons the FDA Rejects Cybersecurity Submissions
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510(k) Cybersecurity
Cybersecurity for FDA 510(k) submissions under the Feb 2026 guidance and Section 524B - what reviewers want, where 510(k)s actually fail, and how to ship a clean package.
- 5
- services
- 5
- guides
- 4
- posts
- 6
- standards
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IDE Cybersecurity
Cybersecurity for FDA Investigational Device Exemption (IDE) submissions - what reviewers expect, how to avoid a Clinical Hold, and how the artifacts roll forward into 510(k)/De Novo/PMA.
- 4
- services
- 3
- guides
- 3
- posts
- 6
- standards
Featured guide12 Critical Threat-Modeling Gaps in Submissions
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Medical Device Penetration Testing
Pen testing built for FDA submissions and connected medical devices - black, gray, and white box methods, scoping, and the standards that map to each.
- 5
- services
- 2
- guides
- 4
- posts
- 4
- standards
Featured guide12 Critical Findings from Medical Device Pen Tests
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Stage 3
Operate & Respond
Postmarket is where the real attack surface lives. These hubs cover continuous monitoring, vulnerability triage, and the coordinated-disclosure program reviewers and researchers both look for.
2 hubs
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Postmarket Medical Device Cybersecurity
Vulnerability monitoring, CVD intake, patching, and FDA reporting for cleared devices - the postmarket program Section 524B now requires.
- 3
- services
- 1
- guides
- 2
- posts
- 4
- standards
Featured guidePostmarket Cybersecurity Readiness Plan
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Coordinated Vulnerability Disclosure (CVD)
Coordinated Vulnerability Disclosure for medical devices - CVD policy, intake, triage, and remediation under FDA postmarket guidance, AAMI TIR97, and ISO/IEC 29147/30111.
- 4
- services
- 4
- guides
- 3
- posts
- 5
- standards
Featured guidePostmarket Cybersecurity Readiness Plan
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Get FDA cleared without the cybersecurity headaches.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.