Qalico provides a real‑time regulatory intelligence platform that monitors updates from over 150 medical device agencies across 120+ countries. Users create device profiles and the AI filters relevant changes, delivering actionable compliance recommendations and direct links to official documents in a single dashboard, streamlining regulatory monitoring for compliance teams.
Funding
Funding not disclosed
Founders
Product
Problem
Medical device manufacturers must continuously track regulatory changes across dozens of agencies and jurisdictions, but the information is scattered across multiple websites, newsletters, and informal sources, making it difficult to ensure complete coverage.
Solution
Qalico offers a real‑time regulatory intelligence platform that monitors updates from over 150 agencies in more than 120 countries. Users create a device profile specifying product codes, target markets, and clinical claims; the system’s AI then filters and analyzes only the changes relevant to that profile. Each update includes a direct link to the official source and an actionable recommendation that outlines the required compliance steps and QMS documentation updates. The platform consolidates all monitoring, impact assessment, and guidance in a single dashboard, reducing the time spent searching for and interpreting regulatory information.
Target Audience
Primary customers are regulatory affairs and compliance teams within medical device manufacturers that need to maintain up‑to‑date certification across multiple global markets.
Features
- AI‑driven monitoring of norms, FDA, EU MDR, PMDA, Health Canada, and 100+ other agencies in real time
- Profile‑based filtering by device type, market, and topics such as Clinical Evaluation, PMCF, IVD, and Technical Files
- Direct links to official regulatory documents to ensure source verification
- Actionable compliance recommendations that translate regulatory changes into concrete QMS tasks
- Coverage of 120+ countries and more than 150 regulatory bodies in one interface
- Dashboard with searchable updates and exportable reports for audit trails