AI-powered compliance gap analysis trusted by regulatory affairs teams at innovative medtech companies. Upload your IEC 62304, ISO 14971, and QMS documentation—get instant, audit-ready GSPR checklists.
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Traditional compliance assessment is slow, expensive, and error-prone
Regulatory teams spend months cross-referencing requirements across IEC 62304, ISO 14971, and GSPR chapters
External compliance consultants charge premium rates for documentation gap assessments
Manual reviews frequently miss requirement gaps that surface during notified body audits
Our AI-powered platform analyzes your technical documentation and generates comprehensive GSPR gap reports
Drag and drop your IEC 62304 software development files, ISO 14971 risk management documentation, and quality management system procedures. Supports PDF, Word, and Excel.
Our AI engine cross-references your documentation against all 23 GSPR chapters, identifying missing requirements, incomplete evidence, and potential non-conformities.
Automatically generate a comprehensive Annex I GSPR checklist mapped to your documentation, ready for notified body submission or internal audit.
Use our compliance dashboard to assign, track, and close gaps with your team. Real-time progress monitoring ensures you're always audit-ready.
Join innovative medtech companies using Captain Compliant to streamline their compliance journey.
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