FDA Submission Support& Free Document Review
Upload your existing cybersecurity documentation — 510(k) sections, cybersecurity management plans, SBOM artifacts — and receive a free preliminary review from our regulatory team within 3 business days.
What We Review
510(k) Cybersecurity Section
Gap analysis against FDA's 2023 cybersecurity guidance and CDRH expectations for premarket submissions.
Cybersecurity Management Plan
Review of your CSMP structure, threat model completeness, and post-market surveillance commitments.
SBOM & CBOM Artifacts
Validation of software and cybersecurity bill of materials format, completeness, and CVE mapping.
De Novo & PMA Packages
Full cybersecurity section review for higher-risk device submissions with detailed deficiency identification.
How the Free Review Works
Upload your documents
Securely upload your existing cybersecurity documentation using the form below. All files are encrypted in transit and at rest.
Expert review within 3 days
A senior MShield regulatory engineer reviews your submission against current FDA guidance and identifies gaps.
Receive your gap report
You receive a structured gap report with prioritized findings and recommended remediation steps — no strings attached.
Upload Your Documents for Free Review
Accepted formats: PDF, DOCX, XLSX. Up to 10 files, 20 MB total. All uploads are encrypted and handled under NDA.
Need Full Submission Support?
Our team can author, review, and submit your complete cybersecurity documentation package.