Threat modeling is the foundation of every credible cybersecurity submission - and the section reviewers scrutinize most. This hub collects our threat modeling service, FDA-aligned methodology, the 12 gaps we see most often, and how STRIDE maps to AAMI SW96 risk management. A submission-grade threat model produces traceable artifacts at four layers: a system and data-flow decomposition that names every trust boundary, asset, and external interface; a STRIDE-per-element analysis that enumerates spoofing, tampering, repudiation, information disclosure, denial-of-service, and elevation-of-privilege threats against each component; a risk evaluation that scores likelihood and harm severity using the device's intended-use and use-environment context, including multi-patient and fleet-level harm scenarios reviewers now expect under the FDA February 2026 final guidance; and a mitigation traceability matrix that maps every accepted threat to a security control, a verification test, and a residual-risk entry in the ISO 14971 risk file. Threat models that skip the trust-boundary map, treat the device as a single black box, or omit multi-patient harm are the single most common driver of first-cycle cybersecurity Additional Information letters. AAMI SW96 is now the bridge reviewers expect between the security threat analysis and the safety risk file, and a threat model that doesn't carry threats into the SW96 risk register reads as incomplete regardless of how thorough the STRIDE work is.
The short answer
A submission-grade medical device threat model decomposes the whole system into data flows and trust boundaries, applies STRIDE per element, rates each threat using intended use and use environment (including multi-patient and fleet-level harm), and traces every threat to a control, a verification test, and a residual-risk entry in the ISO 14971 file through ANSI/AAMI SW96:2023. The FDA's February 2026 guidance treats the threat model as the spine of the submission, and incomplete trust-boundary coverage is the most common driver of first-cycle deficiency letters.
Comprehensive threat modeling per FDA Section V.A.1 - covering supply chain, deployment, environment of use, and decommission risks for the full device system.
Architecture review, control selection, and secure development guidance from concept through V&V - aligned with FDA's Secure Product Development Framework.
Full-service, end-to-end: we deliver 100% of the artifacts FDA reviewers expect for 510(k), De Novo, PMA, PDP, and HDE submissions under §524B, plus IDE applications under 21 CFR 812 and the FDA's February 3, 2026 premarket guidance - traceable, complete, and current.
Defined entries from our MedTech Cybersecurity Standards Glossary.
The deficiency letters reviewers most often write on submissions in this topic area. Each links to the full response playbook.
Reviewers say your STRIDE/attack-tree analysis misses interfaces, trust boundaries, or post-market threat surfaces.
Response playbookReviewers cannot find a cybersecurity risk assessment distinct from the ISO 14971 safety risk file, or the integration is unclear.
Response playbookYour submission is missing one or more of the architecture views FDA 2026 expects (global system, multi-patient, updateability).
Response playbookReviewers find your penetration test scope too narrow, methodology unclear, or testers insufficiently independent.
Response playbook30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ devices supported.
