RegComply AI - FDA 510(k) Compliance Analyzer

Overview

RegComply AI is a Ai platform that provides instant AI-powered compliance analysis for FDA 510(k) medical device submissions.

Features

• Instant Document Analysis - Upload your 510(k) PDF and get compliance feedback in seconds
• Section-by-Section Review - Detailed breakdown of all required FDA sections with severity levels
• Compliance Scoring - Get an overall compliance score and completeness percentage
• AI Chatbot - Ask questions about FDA requirements and submission guidelines
• Print & Download - Generate and export compliance reports
• Fully Responsive - Works seamlessly on desktop, tablet, and mobile devices

Tech Stack

• React 18.2
• Vite (Build tool)
• Tailwind CSS (Styling)
• Lucide React (Icons)

Quick Start

npm create vite@latest regcomply-ai -- --template react
cd regcomply-ai
npm install
npm install -D tailwindcss postcss autoprefixer
npm run dev

What It Does

1. Upload - Drag and drop your 510(k) submission document
2. Analyze - AI analyzes against FDA compliance requirements
3. Review - See detailed findings with recommendations
4. Improve - Use insights to strengthen your submission

Key Sections Analyzed

• Device Description
• Intended Use
• Substantial Equivalence
• Performance Testing
• Labeling
• Biocompatibility

Documentation

• IMPLEMENTATION_GUIDE.md - Setup and architecture
• DEPLOYMENT_GUIDE.md - Deployment options
• FILE_MANIFEST.md - Complete file reference

Status

✅ Production Ready - Ready for deployment and backend integration

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Built for medical device companies to accelerate FDA submissions