Entering the UAE & GCC with a medical device or AI SaMD shouldn’t take months of delays and regulatory uncertainty.

At LIS Consulting, we help MedTech and AI-driven SaMD companies navigate complex regulations and secure approvals faster with a clear, efficient, and compliant pathway.

From initial strategy to final approval, we simplify the entire process:
• Medical Device & SaMD Registration (UAE & GCC)
• Regulatory Strategy & Authority Submissions
• QMS Implementation (ISO 13485 / ISO 14971)
• Market Entry & Expansion Support

Our approach is simple: reduce delays, eliminate rework, and accelerate your time to market.
We work with innovative companies looking to scale in the region and ensure their products reach the market with confidence.

Have a product in mind? Share your device class and target market  we’ll map the fastest route to approval.

LIS Consulting

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