Streamline your quality documentation, detect compliance gaps, and be audit-ready—without manual reviews. Works with your Box folders. No document uploads.
MedComplyAI analyzes your SOPs, CAPAs, DHFs, and Risk files against FDA 21 CFR 820 and ISO 13485—then surfaces clause-level gaps with clear, explainable findings.
Semantic matching maps documents to relevant clauses—flagging missing or weak coverage with evidence snippets.
Export clean PDF summaries and traceability CSVs with direct links back to your Box file versions.
Zero-copy analysis: we don’t store your source documents—only metadata and findings. Read-only Box access with easy revocation.
OAuth sign-in with read-only scope to specific folders (QMS, DHF, Risk, CAPA).
AI parses PDFs/DOCX, chunks content, embeds, and maps to FDA/ISO clauses.
See compliance scores and drill into clause-level evidence and remediation tips.
Generate audit readiness PDFs and traceability CSVs for internal/external reviews.
Founded by medical device quality veterans with 20+ years of experience, MedComplyAI helps growing medtech teams stay compliant without the manual document grind. We complement your QMS by analyzing documents where they live—inside your Box environment.
Join the early-access program and help shape the future of AI-assisted compliance.
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