MedReg AI is an AI-powered regulatory compliance platform designed specifically for biotech and medical device companies. Our platform automates the complex process of regulatory documentation gap analysis, helping you ensure compliance with FDA and EU MDR requirements.
The Challenge of Regulatory Compliance
Medical device companies face significant challenges when preparing regulatory submissions:
- Complex Requirements: FDA 510(k) and EU MDR 2017/745 regulations contain hundreds of specific requirements
- High Costs: Traditional regulatory consulting can cost $50,000-$200,000 per submission
- Time-Consuming: Manual gap analysis can take weeks or months
- Risk of Errors: Missing requirements can lead to costly delays or rejections
How MedReg AI Helps
MedReg AI leverages advanced AI technology to streamline your regulatory compliance process:
1. Automated Gap Analysis
Upload your technical documentation, and our AI automatically:
- Identifies missing or incomplete sections
- Compares your documents against regulatory requirements
- Highlights specific clauses that need attention
- Provides actionable recommendations for improvement
2. Multi-Regulation Support
We support the most critical regulatory frameworks:
- FDA 510(k): Pre-market notification requirements
- EU MDR 2017/745: Medical Device Regulation for European markets
- ISO 13485: Quality management systems
- Amazon Medical Device Requirements: For e-commerce compliance
3. Intelligent Document Analysis
Our platform understands various document types:
- Technical Files
- Clinical Evaluation Reports (CER)
- Risk Management Files (RMF)
- Instructions for Use (IFU)
- Post-Market Surveillance (PMS) Plans
- Labels and Packaging
Who Benefits from MedReg AI
Small to Mid-Size MedTech Companies
Companies with $5M-$200M annual revenue can access enterprise-grade compliance tools without enterprise costs.
Biotech Startups
Pre-market stage companies can ensure their documentation is submission-ready before engaging expensive consultants.
Regulatory Consultants
Compliance professionals can use MedReg AI to deliver faster, more comprehensive analysis to their clients.
Quality Assurance Teams
Internal QA teams can perform continuous compliance monitoring and pre-submission checks.
Key Features
Smart Document Upload
- Drag-and-drop interface for easy document management
- OCR technology for scanned documents
- Automatic section recognition and indexing
Comprehensive Gap Reports
- Detailed analysis of each regulatory requirement
- Direct citations to specific regulation clauses
- Prioritized action items
- Progress tracking
Collaboration Tools
- Team workspaces for cross-functional collaboration
- Comment and annotation features
- Version control and audit trails
- Export reports in multiple formats
Getting Started
Getting started with MedReg AI is simple:
- Create an Account: Sign up at medical-regulation.com
- Create a Project: Select your target regulation (FDA 510(k), EU MDR, etc.)
- Upload Documents: Add your technical documentation and supporting files
- Run Analysis: Let our AI analyze your documents against regulatory requirements
- Review Results: Get a comprehensive gap analysis report with actionable recommendations
- Track Progress: Monitor your compliance improvements over time
Pricing
We offer flexible pricing to meet your needs:
- Professional: $1,000/month per workspace - Includes monthly gap analysis reports
- Enterprise: Custom pricing - Unlimited projects, dedicated support, API access
- Per-Report: $2,500 per comprehensive gap analysis report
Why Choose MedReg AI
Save Time and Money
Reduce regulatory consulting costs by up to 80% while getting faster results.
Increase Confidence
Submit with confidence knowing your documentation has been thoroughly analyzed against all requirements.
Stay Current
Our AI is continuously updated with the latest regulatory changes and guidance documents.
Expert Support
Our team includes regulatory affairs professionals who understand the nuances of medical device compliance.
Learn More
Ready to streamline your regulatory compliance process?
- Schedule a Demo - See MedReg AI in action
- View Pricing - Find the right plan for your organization
- Contact Sales - Speak with our team
MedReg AI is designed to assist with regulatory compliance but does not replace professional regulatory consulting. Always consult with qualified regulatory professionals for final submission decisions.
