Each pillar bundles the services, in-depth guides, glossary entries, and curated blog posts that make up our coverage of that topic.
Everything a MedTech team needs to clear FDA premarket cybersecurity review under Feb 2026 guidance and Section 524B - services, guides, FAQs.
Pen testing built for FDA submissions and connected medical devices - black, gray, and white box methods, scoping, and the standards that map to each.
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.
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.
Vulnerability monitoring, CVD intake, patching, and FDA reporting for cleared devices - the postmarket program Section 524B now requires.
FDA guidance, AAMI, ISO, IEC, and NIST standards that govern medical device cybersecurity - what each one requires and how they connect.
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.
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 for Software as a Medical Device (SaMD) - cloud, mobile, and standalone software under FDA 2026 guidance, IEC 62304/81001-5-1, and Section 524B.
Coordinated Vulnerability Disclosure for medical devices: CVD policy, intake, triage, and remediation under FDA postmarket guidance and ISO/IEC 29147.
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 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.
Keys, certificates, code signing, secure update delivery, and post-quantum planning for FDA-regulated medical devices, with the evidence reviewers expect.
30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
