LENS: The AI-Powered Regulatory Intelligence Platform
RegsDecoded is the evolution of CFR Decoded, expanding coverage to all four major regulatory markets: USA (21 CFR), EU (MDR/IVDR), Canada (CMDR), and Australia (TGA). This comprehensive platform enables regulatory professionals to search, compare, and understand compliance requirements across multiple jurisdictions simultaneously. Key features include cross-region regulatory mapping showing equivalent requirements, an AI-powered research assistant that answers questions with precise citations, a device classification engine for pathway determination, and intelligent search across 2,990+ regulatory sections. With RegsDecoded, you can reduce research time from days to minutes, identify harmonization opportunities, and make informed decisions about global market entry strategies.
This intelligent platform transforms the complex Code of Federal Regulations (21 CFR) into an intuitive, searchable knowledge base designed specifically for regulatory professionals, quality engineers, and medical device manufacturers. Key features include AI-powered contextual summaries that explain regulatory requirements in plain language, intelligent search across 800+ CFR sections with relevance ranking, hierarchical browsing of Part 820 (Quality System Regulation) and related medical device requirements, and personalized research tools including bookmarks, notes with folder organization, and search history. With CFR Decoded, you can reduce regulatory research time from hours to minutes, quickly find answers to compliance questions with precise section citations, and build a comprehensive knowledge base of FDA requirements for your device development projects.