Question 1

What is medical device threat modeling and why does FDA care?

Accepted Answer

Threat modeling is the structured analysis of how an attacker could compromise your device's safety, effectiveness, or data. The FDA's February 2026 premarket cybersecurity guidance, AAMI TIR57, and ANSI/AAMI SW96 all expect a threat model that ties cybersecurity risk to patient safety - not a generic IT checklist. Reviewers look for documented assets, trust boundaries, attack paths, mitigations, and residual risk traced to your ISO 14971 hazard analysis. Without that linkage, expect an Additional Information request.

Question 2

What architecture views do you provide?

Accepted Answer

We deliver the four views FDA reviewers expect: a global system view of every component and interface; a multi-patient harm view that exposes blast-radius scenarios across a device fleet; an updateability and patchability view showing the secure update path from build server to deployed device; and a security use-case view covering normal, misuse, and abuse cases. Each view is annotated with trust boundaries, data flows, and the cybersecurity controls applied - covering device, cloud, mobile, hospital network, home network, update servers, and external services.

Question 3

Do you align with the latest FDA cybersecurity guidance?

Accepted Answer

Yes. Every engagement aligns with the FDA's February 2026 final premarket cybersecurity guidance and Section 524B of the FD&C Act. Artifacts are built to the standards reviewers cite in deficiency letters: AAMI TIR57, AAMI TIR97, ANSI/AAMI SW96, ISO 14971, IEC 62304, IEC 81001-5-1, NIST 800-30, MDCG 2019-16, and the QMSR (21 CFR Part 820). The threat model, SBOM, and labeling are formatted for eSTAR submission so your regulatory team can drop them straight into the package.

Question 4

Can you work with our existing QMS and regulatory team?

Accepted Answer

Yes. We deliver evidence in formats your QMS can absorb - ISO 13485 / QMSR-friendly templates, version-controlled artifacts, and traceability that maps to your design history file. We collaborate directly with regulatory, quality, clinical, and engineering stakeholders, attend your design reviews, and produce the threat model in a format that drops into your submission narrative without rework. If you use Jama, Polarion, Helix ALM, or a similar requirements tool, we'll deliver in a format that round-trips cleanly.

Question 5

Do you support 510(k), De Novo, PMA, and IDE submissions?

Accepted Answer

Yes. We tailor the depth of the threat model and supporting evidence to the pathway, device class, and connectivity profile. For IDE submissions we focus the package on cybersecurity risks that could affect study-subject safety - architecture views, threat model with clinical-environment assumptions, and a security risk assessment that gives the reviewer enough confidence to avoid a Clinical Hold under 21 CFR 812.42. For 510(k), De Novo, and PMA we deliver the full Section 524B / February 2026 guidance package that drops into eSTAR or PMA modular content.

Question 6

What do you need from our team to get started?

Accepted Answer

A 30-minute discovery call, then access to your current architecture diagrams, intended use statement, indications for use, interface inventory, third-party component list or draft SBOM, and any existing risk or cybersecurity documentation. We also benefit from a short technical walkthrough with engineering. We bring the methodology, templates, regulatory mapping, and the senior threat modeler who runs the engagement end to end - so your team isn't asked to learn AAMI SW96 on a deadline.

Question 7

How long does a typical threat modeling engagement take?

Accepted Answer

Most engagements complete in 3-6 weeks depending on system complexity, number of interfaces, connectivity profile (BLE, Wi-Fi, cellular, cloud), and how much existing documentation we can build on. Single-interface devices often finish closer to three weeks; multi-component connected platforms with cloud back-ends and mobile apps run closer to six. We provide a fixed-fee quote and a written timeline within 24 hours of the scoping call - no hourly billing and no scope creep.

Question 8

What if FDA issues a cybersecurity deficiency?

Accepted Answer

We handle that too. Our deficiency-response service rebuilds or extends the threat model to address reviewer feedback within the 180-day deficiency clock, and existing threat modeling clients get priority response. The work typically includes a targeted re-analysis of the cited gap, additional architecture views or misuse cases as needed, updates to the security risk assessment, and a written response narrative the reviewer can follow line by line. Most deficiency packages turn around in 2-4 weeks.

Question 9

Do you include security risk traceability?

Accepted Answer

Yes. Every identified threat is mapped to its control, the cybersecurity risk assessment entry, the test or evidence that validates the control, the residual risk after mitigation, and the corresponding safety risk in your ISO 14971 hazard analysis. The traceability matrix is delivered as a structured artifact (typically a controlled spreadsheet or requirements-tool export) so reviewers can follow the chain from threat to test to residual risk without manual cross-referencing - which is exactly what they look for under AAMI TIR57.

Question 10

Can you support teams that already have a threat model?

Accepted Answer

Absolutely. Many of our engagements begin as gap assessments against an existing threat model. We benchmark the current artifact against the February 2026 FDA guidance, AAMI TIR57, and ANSI/AAMI SW96, identify missing architecture views (most often the multi-patient and updateability views), rework trust boundaries that are too coarse, add the misuse-case and abuse-case analysis reviewers expect, and refresh the safety-impact mapping. You keep your existing artifact as the baseline; we make it submission-ready.

FDA-compliant threat modeling for medical device submissions.

Why most threat modeling fails medical devices

Incomplete threat modeling

Non-compliant documentation

Increased patient risk

Threat modeling built for medical devices

Global system view

Multi-patient harm view

Patchability & lifecycle view

Security use cases & states

What a STRIDE / AAMI threat model covers

Our process simplifies FDA clearance

1 · Discovery & scoping

2 · Architecture intake

3 · Threat modeling workshop

4 · FDA-ready package

Reviewer-ready deliverables in one engagement

Public premarket cybersecurity history

Architecture View and STRIDE gap as recurring deficiency

Related Premarket services

Full-Service FDA Premarket Cybersecurity

FDA Deficiency Response

FDA-Compliant SBOM Services

Medical Device Threat Modeling for these segments

Resources on this topic

Guides

Articles

Try the free tool first.

Threat Model Starter

Section 524B Applicability

SaMD / SiMD + EU Rule 11

Questions medical device teams ask before threat modeling

Backed by MedTech leaders.

Medical Device Threat Modeling - scoped, fixed-fee, FDA-ready.