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
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.
6 hubs
FDA guidance, AAMI, ISO, IEC, and NIST standards that govern medical device cybersecurity - what each one requires and how they connect.
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.
Featured guideISO/TR 80002-2 and Validating Cybersecurity Tools (2026)
Explore hubCybersecurity for AI/ML medical devices: PCCP, GMLP, model evasion, data poisoning, model inversion, performance drift, and the FDA's expectations under the 2026 guidance and 2025 draft AI guidance.
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.
Keys, certificates, code signing, secure update delivery, and post-quantum planning for FDA-regulated medical devices, with the evidence reviewers expect.
SBOM generation for FDA premarket submissions, CVE/KEV monitoring, and the formats (SPDX, CycloneDX) reviewers expect in 510(k), De Novo, PMA, and IDE submissions.
Featured guideThe MedTech Cybersecurity Standards Decoder
Explore hubStage 2
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.
5 hubs
Everything a MedTech team needs to clear FDA premarket cybersecurity review under Feb 2026 guidance and Section 524B - services, guides, FAQs.
Cybersecurity for FDA 510(k) submissions under the Feb 2026 guidance and Section 524B: what reviewers expect, common deficiencies, and how to ship clean.
Cybersecurity evidence for Class III PMA submissions: SPDF artifacts, threat modeling, SBOM, pen testing, and PMA-supplement change control under the FDA's 2026 guidance.
Cybersecurity for FDA IDE submissions: what reviewers expect, how to avoid a Clinical Hold, and how artifacts roll forward into 510(k), De Novo, or PMA.
Pen testing built for FDA submissions and connected medical devices - black, gray, and white box methods, scoping, and the standards that map to each.
Featured guide12 Critical Findings from Medical Device Pen Tests
Explore hubStage 3
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
Vulnerability monitoring, CVD intake, patching, and FDA reporting for cleared devices - the postmarket program Section 524B now requires.
Coordinated Vulnerability Disclosure for medical devices: CVD policy, intake, triage, and remediation under FDA postmarket guidance and ISO/IEC 29147.
Featured guidePostmarket Cybersecurity Readiness Plan
Explore hub30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
