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Regix AI

Accelerate Your FDA and CE Compliance with AI-Powered Automation

Regix AI helps digital health startups streamline regulatory approval — auto-generating documents, tracking changes, and keeping you audit-ready from day one.

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Good evening, Sasha

Your compliance journey is on track

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Overall Progress

0%

Compliance Roadmap

Ready

4 documents

In Progress

2 documents

Pending

3 documents

Auto-draft IEC Report

AI-generated report ready for review

Upcoming Deadlines

  • FDA Submission2 days
  • GDPR Assessment5 days

How Regix AI Helps You Stay Compliant

Track, collaborate, and manage your regulatory journey with real-time updates and AI support.

Track Every Compliance Document in Real Time

Stay on top of every regulatory task — with a live dashboard that tracks document status, approvals, and submission progress.

  • Monitor CE, UKCA, and FDA compliance status in one view
  • Instantly see document states: Draft, Reviewed, Submitted
  • Visualise progress across milestones with smart tracking

Document Status

Updated 2h ago
Technical File
Reviewed
Clinical Evaluation
Submitted
Risk Analysis
Draft
Overall Progress68%

Collaborate on Docs with Built-in AI

Write, review, and export regulatory documents — with AI-powered clause suggestions and real-time team collaboration.

  • Auto-suggest missing clauses based on ISO, MDR, and FDA guidance
  • Collaborate with your team through live in-line comments
  • Export to PDF, DOCX, or JSON in one click

Document Editor

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The device is classified as Class IIa under EU MDR Rule 11.

AI

Suggested clause: Include reference to ISO 13485:2016 Section 4.2.3 for document control procedures.

Clinical evaluation follows MEDDEV 2.7/1 rev 4 guidelines.

Proactive Compliance, Powered by Agentic AI

Regix watches your codebase and updates compliance documentation automatically — so you're never out of sync.

Connect GitHub to detect risk-impacting code changes

Automatically scan commits and pull requests to identify changes that may impact your regulatory compliance.

Auto-update risk registers, technical files, and audit logs

Keep your documentation in sync with your codebase as your product evolves.

Alert your team when compliance actions are needed

Get notified about potential compliance issues before they become problems.

Log every change for audit-readiness

Maintain a comprehensive audit trail of all changes and actions for regulatory inspections.

GitHub Commit Detected

New API endpoint added with user data access

AI Analyzes Impact

Identifies GDPR implications and security considerations

Updates Documentation

Adds new entries to risk register and technical file

Notifies Team

Alerts QA team to review and approve changes

Documentation Updated Automatically

Agentic AI Integration: Your Autonomous Compliance Partner

More than just automation — Regix AI acts, adapts, and assists across your compliance lifecycle.

Regix AI Assistant

Active

I need to prepare for our FDA submission next month.

I've analyzed your product data and identified 3 key actions needed for your FDA submission:

  • Generate DPIA for US market
  • Update Technical File with recent test results
  • Missing: Software validation protocol
Proactive Alert

I noticed your GitHub repo was updated with new API endpoints. This may require updates to your risk assessment document to maintain ISO 14971 compliance.

Features of our Agentic AI Engine:

Understands your product

Adapts compliance workflows based on your specific product characteristics and target markets.

Proactive assistance

Suggests actions, document updates, or alerts — without being prompted.

Comprehensive audit trails

Logs all changes with justification for audit trails and regulatory evidence.

Seamless integration

Integrates into your dashboard as a live assistant, always ready to help.

Example Prompts

"Generate CE submission pack"
"Check if our QMS meets ISO 13485"
"What evidence is missing for this claim?"