Documented Medical Device Cybersecurity Consultancies
Section 524B of the FD&C Act made cybersecurity a reviewable element of your submission, not an appendix to it. A cyber device going through 510(k), PMA, or De Novo now needs a security risk management plan, a defensible threat model, a machine-readable SBOM, and a postmarket monitoring story that survives inspection.
The consultancies below are verified on what actually clears review: named deliverables, submission-type track records, FDA meeting experience, and NTIA-compliant SBOM tooling, visible before you ever send an RFP.
What renders on this page
- ▸Firm matrix filtered by 524B deliverable, SRMP, threat model, SBOM, penetration testing report, SRMR, labeling, VDP
- ▸NTIA-compliant SBOM tool checkmarks (CycloneDX 1.5+, SPDX 2.3+)
- ▸Submission-type track records, 510(k), PMA, De Novo, with Q-sub meeting experience flags
- ▸Standards alignment, AAMI TIR57, IEC 62304, IEC 81001-5-1, UL 2900-2-1
- ▸"Request Secure RFP" form pre-wired to the FDA 524B RFP template
What Section 524B actually requires
A cyber device (one that includes software authorized for device functions, or that connects to the internet) triggers 524B regardless of risk classification. Reviewers expect a Security Risk Management Plan integrated with your ISO 14971 file, four security architecture views, a known-vulnerability assessment against KEV, and lifecycle support commitments that name patch SLAs.
Deliverables that clear review
The strongest predictor of first-cycle clearance is completeness: threat models that trace to risk controls, SBOMs that reviewers can parse, penetration testing reported in FDA-recognized methodology, and labeling that carries the cybersecurity information users actually need. Directory records track which firms have done this (by submission type) before you commit.
Postmarket is half the story
524B made postmarket cybersecurity a standing obligation: monitoring plans, coordinated vulnerability disclosure, and update timelines. The firms here build those programs into quality systems (CAPA, design control) rather than running them as a parallel track that fails inspection.
How we vet medtech firms
CSSLP and CISA credentials are checked against issuers. Submission experience is documented per type (510(k), PMA, De Novo) not as a total count. SBOM tooling is verified for both NTIA minimum elements and FDA-preferred formats. Case studies are anonymized but specific: device class, submission type, and review-cycle outcome.
Frequently asked questions
What does an FDA 524B consultant do?
Three things, usually in sequence: author or repair the premarket cybersecurity package (SRMP, threat model, SBOM, vulnerability assessment, SRMR), prepare the submission for reviewer expectations, and stand up the postmarket program (monitoring, CVD, patch SLAs) that the premarket package promises.
Do I need a threat model or a full security risk management file?
Both, and they are not the same artifact. The threat model feeds the Security Risk Management Report; reviewers reject packages where threat modeling and risk management read as separate documents written by different teams. Verified firms integrate both under AAMI TIR57 and ISO 14971.
What SBOM format does FDA expect?
Either machine-readable format FDA recognizes (CycloneDX 1.5+ or SPDX 2.3+) covering NTIA minimum elements. The directory shows which firms generate SBOMs automatically in device CI/CD versus manually, because automation predicts how sustainable your postmarket SBOM will be.
Can one firm handle premarket and postmarket?
Some can; many specialize. The directory separates premarket deliverable authors, penetration testing specialists, and postmarket program operators so you can assemble a bench instead of forcing one consultancy into the wrong scope.