Enterprise Europe Network
HomeParticipantsMarketplace

ProductUpdated on 17 November 2025

The Regulatory Expert: AI System for MedTech Compliance

Geschäftsführer & KI-Experte, ValidateML GmbH at ValidateML GmbH

Konstanz, Germany

About

The "Regulatory Expert" is a specialized intelligence platform designed to be the central brain for your RA/QA team.

Unlike generic LLMs (like ChatGPT), our system is built for the high-stakes world of medical device compliance. It provides full traceability for every claim, referencing the exact source and paragraph from the official documentation.

Key Features:

  • Deep Research Workflow: An agent-based system that mimics the analytical process of a top-tier human expert.

  • Comprehensive Knowledge Base: Pre-loaded and continuously updated with MDR, IVDR, key standards (ISO 13485, IEC 62304), and MDCG guidance.

  • Internal QMS Integration: Can be securely connected to your internal documentation (SOPs, technical files) to provide context-aware answers.

  • Data Security: LLM-agnostic architecture allows for deployment on your trusted cloud (e.g., Azure) or even on-premise, ensuring your data never leaves your control.

Schedule a 15-minute live demo with us at MEDICA to see the platform in action.

Looking for

  • Buyer
  • Re-Seller/Wholesaler
  • License partner
  • Demonstration / Pilot projects

Applies to

  • E-HEALTH
  • INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES
  • LIFE SCIENCE
  • MEDICINE
  • ROBOTICS AND AUTOMATION

Organisation

ValidateML GmbH

Other

Konstanz, Germany

Similar opportunities

  • Service

    Pilot Project: Get 3 Audit-Ready Answers to Your MDR/IVDR Questions

    • E-HEALTH
    • MEDICINE
    • Consulting
    • LIFE SCIENCE
    • Testing & Analysis
    • Research & Development
    • ROBOTICS AND AUTOMATION
    • IPR, Legal and tax advisory

    Kai Haase

    Geschäftsführer & KI-Experte, ValidateML GmbH at ValidateML GmbH

    Konstanz, Germany

  • Expertise

    Medical Compliance & Quality Assurance

    • E-HEALTH
    • INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES

    Barend Smet

    President and Co-Founder at Thaumatec Tech Group

    Wroclaw, Poland

  • Service

    COMPLIANCE ASSURANCE

    • Certification
    • INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES

    Barend Smet

    President and Co-Founder at Thaumatec Tech Group

    Wroclaw, Poland