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:
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Deep Research Workflow: An agent-based system that mimics the analytical process of a top-tier human expert.
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Comprehensive Knowledge Base: Pre-loaded and continuously updated with MDR, IVDR, key standards (ISO 13485, IEC 62304), and MDCG guidance.
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Internal QMS Integration: Can be securely connected to your internal documentation (SOPs, technical files) to provide context-aware answers.
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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
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 at Thaumatec Tech Group
Poland
Service
- Certification
- INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES
Barend Smet
President at Thaumatec Tech Group
Poland