MedoQi IntelliVigilance™

IntelliVigilance is an advanced AI-powered platform designed to revolutionize complaints handling, vigilance reporting, and post-market surveillance (PMS) for medical devices and in-vitro diagnostics (IVDs). Built on global regulatory frameworks, it seamlessly integrates automation, intelligence, and compliance to help manufacturers, authorized representatives, and healthcare organizations meet their regulatory obligations efficiently.

Automated Complaint Intake: Captures complaints from multiple channels (emails, portals, chatbots, call centers, social media, SMS, etc.)
Intelligent Categorization & Coding: AI-driven classification of complaints into categories and types aligned with IMDRF coding standards (Annexes A–F).
Regulatory Vigilance & Reportability: Automatically evaluates complaints for regulatory reportability. Prepares jurisdiction-specific reporting forms (e.g., EU MIR, FDA MedWatch 3500A, CDSCO MDAE Form, Health Canada FRM-0037, TGA MDIR)
Technical Investigation & Root Cause Analysis: Facilitates systematic product investigations, testing, and root cause determination. Aligns findings with IMDRF Annex B–D for structured reporting.
Automated Workflow & Case Lifecycle Management: End-to-end complaint tracking across lifecycle statuses: Open → Complaint Review → Investigation → Investigation Review → Final Review → Closed/Voided.
Global Regulatory Intelligence: Embedded knowledge engine for country-specific vigilance timelines and reporting obligations.
Post-Market Surveillance (PMS) & Analytics: Real-time dashboards and trend analysis for adverse events, device failures, and recurrence risks. Supports PMS reporting, safety signal detection, and regulatory inspections.