About MedComplyAI
MedComplyAI helps medical device teams achieve audit readiness for FDA 21 CFR 820 and ISO 13485 by automatically analyzing quality documentation, surfacing clause-level gaps, and generating clear, exportable reports.
Built by Medical Device Quality Experts
MedComplyAI was founded by industry veterans with 20+ years of experience across QMS, CAPA, risk management, and design controls. Our goal is to give SMB and mid-market medtech companies an intelligent co-pilot that reduces manual review hours while improving consistency and traceability.
What We Do
Map your SOPs, CAPAs, DHFs, and risk files to FDA & ISO clauses and highlight missing coverage.
How We Do It
AI-assisted parsing, semantic search, and explainable findings with evidence snippets.
Security First
Works with your Box folders using read-only access. Zero-copy analysis of source docs.
Contact
Questions? Reach us at support@medcomplyai.com.