Upload your medical device documentation and compare it against EU MDR, FDA, ISO and other regulatory guidance, or track drift between document versions. Our AI pinpoints every gap with actionable suggestions.
From document upload to detailed gap reports, Assurance Lens handles your entire medical device compliance workflow.
Upload PDF, Word, and text documents. Support for multiple files per project with drag-and-drop ease.
Analyzed against pre-loaded official guidance from EU MDR, FDA 510(k), ISO 13485, ISO 14971, IEC 62304, and more.
AI quotes exact requirements from guidance, explains the gap, and suggests specific modifications.
Compare against requirements for EU, US, UK, Canada, Australia, Japan, and more target markets.
Track each gap through remediation: Open, In Review, Resolved, or Accepted Risk with full audit trail.
Export gap analysis as CSV, branded PDF, or via API for integration with your QMS workflow.
Compare document versions (e.g. Design Input v1 vs v2) and surface drift, contradictions, and added or removed content.
Three simple steps to full compliance visibility.
Create a project, select your target market and product code, then upload your technical files and any supplementary guidance.
Our AI compares your documentation against official regulatory requirements, identifying every gap with precision.
Get a structured gap report with exact requirements quoted, severity ratings, and specific modification suggestions.