Our features
Powerful AI features to transform your regulatory work
Each feature is designed to save you time and ensure compliance with the latest regulations.

Regulatory Watch

Stop drowning in regulatory updates

Monthly personalized intelligence for your specific device and markets

  • Monitors EU, US, and international sources
  • Impact assessments with priority levels and action recommendations
  • Pre-filled QMS-ready templates (ISO 13485 compliant)
  • Filtered by your GMDN/EMDN codes and target markets
  • Monthly reports delivered to your inbox
Get personalized intelligence

Literature Review

Automate your systematic literature reviews

Streamline your research process with AI-powered literature review

  • Searches PubMed, OpenAlex, and other NB-approved databases
  • Automatic inclusion/exclusion of publications based on your criteria
  • Extracts all relevant data points for CER report inclusion
Coming soon

AI Expert Chatbot

Qalico

Get instant, cited answers to complex QA/RA questions

Your AI quality and regulatory research assistant

  • Trained on FDA, EU-MDR, and more coming soon
  • Built with QARA experts on millions of pages of regulatory documentation
  • Regularly updated sources
Coming soon

Post-Market Surveillance

Monitor incidents and adverse events automatically

Stay informed about safety signals and market trends

  • Tracks FDA MAUDE, TPLC, and other databases
  • Alerts by product code and device type
  • Automated trend analysis and competitor monitoring
Coming soon

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Qalico
AI-powered regulatory intelligence for medical device professionals
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