Documented FDA 524B Premarket Cybersecurity Consultancies
You are searching for an FDA 524B threat modeling consultant because the threat model is where reviewers look first, and where most submissions fail: threat identification that never traces to the risk file, attack paths that ignore the actual device architecture, security architecture views that read as diagrams without rationale.
The firms below are verified on the deliverables behind the search: threat models integrated with Security Risk Management Plans, NTIA-compliant SBOM tooling, and submission track records by type, 510(k), PMA, De Novo.
What renders on this page
- ▸Matrix of firms matching framework_compliance -> fda_524b = true
- ▸NTIA-compliant SBOM tool checkmarks (CycloneDX 1.5+, SPDX 2.3+)
- ▸Submission-type track records with review-cycle outcomes
- ▸Direct "Request Secure RFP" form pre-wired to the FDA 524B template
What a 524B threat model must do
Identify threats against the deployed device architecture, trace attack paths to assets, connect to risk controls in the SRMP, and feed the Security Risk Management Report, under AAMI TIR57 alignment with ISO 14971. Directory case records show which firms have done this through first-cycle clearances, by submission type.
Threat modeling is one deliverable in a set
The full 524B package: SRMP, threat model and architecture views, SBOM, known-vulnerability assessment against KEV, SRMR, cybersecurity labeling, VDP, and the postmarket monitoring plan. Firms here are filtered by the full deliverable set they author, so you buy the bench you actually need, not a threat-model-only engagement that strands the rest of the submission.
How the SBOM checkmarks work
The NTIA minimum elements are the floor: supplier, component, version, identifiers, dependencies, author, timestamp. The checkmark means the firm generates machine-readable SBOMs (CycloneDX 1.5+ or SPDX 2.3+) automatically in CI/CD where indicated, the difference between a SBOM that is current at submission and one that is current until the next build.
Send a secure RFP
The 524B RFP template captures device class, submission type, product codes, deliverables in scope, and timeline. Verified firms respond with standardized proposals you can compare deliverable by deliverable. No sales calls to get a quote.
What fda 524b threat modeling consultant engagements typically cost, and what drives the price
No honest page quotes a single number, because the price of fda 524b threat modeling consultant work varies by scope. The drivers that move quotes are the number of devices and device families in scope, and whether the work is premarket (submission support) or postmarket (monitoring and patching), the maturity of your existing documentation, a draft SBOM and threat model cost less to review than to build from zero, and the stage of your FDA submission calendar, work compressed against a submission deadline is priced differently from work scheduled ahead of it. For real numbers, use the verified directory's rate data and from structured RFP responses with real quotes from device-security consultancies.
How long it takes
Premarket cybersecurity documentation typically runs alongside your regulatory timeline, not after it, SBOM and threat-model work starts with design inputs.
Penetration testing is bounded by test-unit availability and lab scheduling, not by the firm's calendar alone.
Postmarket vulnerability management is continuous by definition, the first engagement sets the monitoring rhythm.
What to prepare before you engage a firm
The firms you are about to compare will scope faster (and quote more accurately) if you arrive with your intended-use statement and device architecture documentation, a software bill of materials (SBOM), or a statement of where you stand on building one, any existing threat model or risk assessment artifacts, even drafts, and the regulatory pathway you are pursuing (510(k), De Novo, PMA) and where you are in it.
Common mistakes to avoid when choosing
treating cybersecurity documentation as a late submission-stage checkbox rather than a design-input activity
commissioning a penetration test before the threat model exists, testing against an unranked attack surface wastes budget
buying SBOM tooling without the engineering process to keep the SBOM current, an SBOM that goes stale at submission helps no one
What happens after you engage
A well-run fda 524b threat modeling consultant engagement follows a predictable arc: a gap assessment against FDA's premarket and postmarket cybersecurity guidance (and Section 524B requirements where they apply), then a documentation work plan sequenced against your submission calendar, then the technical work (threat modeling, testing, SBOM remediation) with evidence in the format reviewers expect, and finally submission support: reviewer-question responses and postmarket handoff. If a firm cannot describe this arc for your environment, that itself is a finding.
Frequently asked questions
Can a threat modeling consultant also write the SRMP?
Most verified firms author the integrated package (SRMP, threat model, SBOM, SRMR) because reviewers read them as one story. The directory filter shows which firms do full packages versus specialized deliverables.
How much does FDA 524B threat modeling cost?
Verified medtech firms run $250–$350+/hour mid-band and $350+/hour for submission-lead specialists. A Class II threat-model-and-integration engagement typically lands mid five figures; full package authorship runs higher. The RFP captures scope so quotes are comparable.
How fast can a consultant start?
Directory firms quote start dates against real capacity. For a submission already in preparation, verified firms with first-cycle records are worth a longer lead time than a faster start without one.
How much does medical device cybersecurity consulting cost?
Cost tracks device-family count, documentation maturity, and your submission stage, the three drivers above. The verified directory lists device-security consultancies with disclosed rate data where available, and structured RFP responses return real quotes for your specific device scope.
When in the device lifecycle should we engage a security firm?
Before the threat model is due as a design input, not at submission. Firms engaged early can shape the SBOM and threat-model work into the design process; firms engaged late can only document what already happened.