Worried About FDA Cybersecurity Requirements? We Handle It All — So You Don’t Have To.

We handle your end-to-end FDA cybersecurity submission, typically including SPDF support, SBOMs, threat modeling, penetration testing, and the necessary documentation for a review-ready package.

We support FDA cybersecurity submissions for 510(k), De Novo, and PMA, tailoring the documentation and testing to your specific submission type and device architecture.

Yes. We produce FDA-ready documentation content (including SPDF-aligned deliverables), so you’re not piecing together templates and narratives on your own.

Yes. We create a complete SBOM tailored to your device and use it to support vulnerability visibility, component risk decisions, and defensible documentation.

We support penetration testing and security testing activities, including SAST/DAST and vulnerability scanning, and then translate the results into clear, FDA-compliant evidence and remediation guidance.

Yes. We build documentation to support FDA expectations and broader global alignment, helping reduce rework across markets.

If cybersecurity issues are flagged, we work with you at no additional cost to resolve them quickly and strengthen the evidence—so you can get back on track without unnecessary delays.

Yes. Retesting is included, allowing you to validate fixes and build a clean, defensible evidence trail before submission.

Typically, this includes system architecture details, software/firmware build information, lists of third-party components, the intended use/deployment environment, and any existing risk or security documentation. We’ll identify gaps during the initial strategy/discovery session.

Yes. If you require ongoing coverage, we can provide post-market monitoring and vulnerability management, ensuring you stay protected and compliant as new threats emerge.

Pricing depends on device complexity, architecture, submission type (510(k), De Novo, PMA), and the amount of existing evidence (SBOM, risk file, test results). Following a brief scoping call, we provide a fixed-scope proposal with clearly defined deliverables.

Timelines vary based on device complexity and the team's ability to provide inputs quickly, but most projects follow a structured schedule: discovery → threat modeling → testing → documentation → revisions. We’ll align milestones to your FDA submission date.

Yes. If you have a firm date, we can prioritize the highest-impact deliverables first (e.g., threat model + SBOM + test plan/evidence + key narratives) and then complete remaining items in parallel where possible.

We’ll ask for architecture diagrams, software/firmware details, third-party component lists, intended use and environment, and any existing risk/security documentation. Your team’s time is usually front-loaded during discovery and then lighter during review cycles.

Great—we’ll reuse what’s solid, fill gaps, and reformat/strengthen it to match FDA expectations. The goal is to avoid rework while making the package reviewer-friendly.

Yes. We don’t just hand you findings; we help prioritize remediation, clarify what matters most for safety/risk, and support retesting so you have defensible closure evidence.

You own your deliverables. We structure documentation so it can be reused and updated for future versions, new indications, or additional markets.

Yes. We help draft responses, provide supporting evidence, and close documentation gaps quickly, ensuring the review stays on track.