Overview
About LIS Consulting
Regulatory Affairs, Market Access & AI-Driven SaMD | GCC & Europe | MedTech
LIS Consulting FZCO is a Dubai-based regulatory affairs and market access firm supporting manufacturers in achieving compliant and scalable market entry across the GCC and Europe.
We combine deep regulatory expertise with AI-driven medical technology insight to support both traditional devices and next-generation digital health solutions.
We advise on regulatory frameworks including:
• Regulation (EU) 2017/745 (EU MDR)
• ISO 13485 – Quality Management Systems
• ISO 14971 – Risk Management
• Regulation (EU) 2017/746 (EU IVDR)
• UAE registrations with Ministry of Health and Prevention (MOHAP)
• Saudi Arabia registrations with Saudi Food and Drug Authority (SFDA)
Our Expertise Covers:
• AI-driven SaMD regulatory strategy (EU & GCC)
• MDR/IVDR technical documentation remediation
• Clinical evaluation & performance strategy
• QMS implementation and audit readiness
• Authority submissions and lifecycle compliance
• Regulatory due diligence for digital health and MedTech investments
We operate at both strategic and execution levels, ensuring manufacturers of AI-enabled and traditional medical technologies achieve sustainable market access while mitigating regulatory and commercial risk.
📍 Based in the UAE | Active across GCC & Europe
🌍 www.lisconsultgroup.com
LIS Consulting FZCO is a Dubai-based regulatory affairs and market access firm supporting manufacturers in achieving compliant and scalable market entry across the GCC and Europe.
We combine deep regulatory expertise with AI-driven medical technology insight to support both traditional devices and next-generation digital health solutions.
We advise on regulatory frameworks including:
• Regulation (EU) 2017/745 (EU MDR)
• ISO 13485 – Quality Management Systems
• ISO 14971 – Risk Management
• Regulation (EU) 2017/746 (EU IVDR)
• UAE registrations with Ministry of Health and Prevention (MOHAP)
• Saudi Arabia registrations with Saudi Food and Drug Authority (SFDA)
Our Expertise Covers:
• AI-driven SaMD regulatory strategy (EU & GCC)
• MDR/IVDR technical documentation remediation
• Clinical evaluation & performance strategy
• QMS implementation and audit readiness
• Authority submissions and lifecycle compliance
• Regulatory due diligence for digital health and MedTech investments
We operate at both strategic and execution levels, ensuring manufacturers of AI-enabled and traditional medical technologies achieve sustainable market access while mitigating regulatory and commercial risk.
📍 Based in the UAE | Active across GCC & Europe
🌍 www.lisconsultgroup.com