HealthCapital Berlin Brandenburg

digitalHealthCapital@DMEA2026

20 – 24 Apr 2026 | Berlin, Germany

ProductUpdated on 10 April 2026

AgentQAMed - AI-Powered Predictive Quality Assurance for Medical Devices

CEO at Agentize.eu

Budapest, Hungary

About

AgentQA-Med is the first EU AI Act-compliant predictive quality assurance system for medical devices. It replaces calendar-based inspection with condition-based, AI-driven monitoring — predicting device failures before they occur and maintaining continuous regulatory compliance automatically.

The system deploys autonomous AI agents at the institutional edge, ensuring patient data never leaves the facility. Device coverage includes ventilators, defibrillators, and imaging equipment. The architecture is fully aligned with MDCG 2025-6 / AIB 2025-1 guidance (joint MDR and AI Act application), featuring explainable AI decision chains and continuous audit trails.

Co-developed with Verlab Research Institute

Organisation

Agentize.eu

Company

Budapest, Hungary

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