Your Regulatory Gateway to New Medical Device Markets (Europe & GCC)

🇦🇪🇪🇺 LIS Consulting (Reg. No. DSO-FZCO-7648) is a Dubai-based regulatory affairs consultancy specialising in end-to-end support for manufacturers seeking compliant market access in Europe and the Middle East. Founded and operated from Dubai Silicon Oasis, LIS Consulting brings deep regulatory expertise across a broad range of product categories: medical devices, in-vitro diagnostics (IVDs), Software as a Medical Device (SaMD), AI-driven medical devices, and personal care products. Our consultants guide clients through every stage of the regulatory lifecycle from initial strategy and gap analysis, to technical documentation, clinical evaluation, submission management, and post-market obligations. Whether you are preparing a CE marking dossier under MDR 2017/745 or IVDR 2017/746, navigating Gulf market registrations, or bringing an AI-powered device to market for the first time, we provide the expertise and hands-on support to get you there efficiently and compliantly. Our areas of expertise include: Medical devices (Class I to III) CE marking, MDR, Gulf & MENA submissions In-vitro diagnostic devices (IVDs), IVDR compliance and registration Software as a Medical Device (SaMD) and AI-driven medical devices Personal care and cosmetic products.

About Us

Healthcare Regulatory Affairs in the UAE and Other GCC Countries.

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Our Services

✅ Our Regulatory Services cover the UAE 🇦🇪, the Gulf Cooperation Council (GCC), and Europe 🇪🇺

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Contact Us

📞 Contact LIS Consulting – Healthcare Regulatory Experts in Dubai

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GCC Post-Market Surveillance (PMS) Compliance – Medtech Manufacturer

A multinational medical device company with EU MDR-aligned PMS identified compliance gaps across GCC vigilance requirements during an internal audit. Challenge: Non-harmonised PMS obligations across Saudi Arabia (SFDA), UAE (MOH/DOH/DHA), and other GCC countries created risks around incident reporting, FSCAs, and PSUR submissions. Our Approach: LIS Consulting mapped GCC requirements, identified key gaps, and redesigned the PMS system with a unified vigilance calendar, harmonized incident reporting criteria, bilingual FSCA templates, SFDA-aligned PSUR process, and staff training. Outcome: A single integrated PMS system now ensures full MDR + GCC compliance, with clear responsibilities and tracked deadlines. A follow-up audit confirmed zero vigilance gaps.

UAE Medical Device Registration – MOHAP & EDE

A European orthopedic implant manufacturer engaged LIS Consulting to support its expansion into the UAE market and navigate the country’s multi-authority regulatory framework. Challenge: Securing registrations across MOHAP & EDE, appointing a local authorised representative, and managing differing documentation, portal, and compliance requirements. Our Approach: LIS Consulting defined the optimal market access strategy, supported the appointment of a UAE authorised representative, prepared and submitted registration dossiers, managed authority queries, and coordinated registration timelines. Outcome: Full market access was achieved across MOHAP & EDE, enabling nationwide distribution and establishing a sustainable framework for future product registrations and renewals.

Bringing an AI-powered MD to the European market

A MedTech startup developing an AI-based lung nodule detection software engaged LIS Consulting to secure CE marking in Europe. Challenge: Determining the correct regulatory pathway under MDR, classifying the software as a Class IIb SaMD, generating sufficient clinical evidence, and addressing AI-specific requirements such as explainability and future algorithm updates. Our Approach: LIS Consulting developed the regulatory strategy, prepared the SaMD classification rationale, structured the clinical evaluation, and established a process for managing future AI modifications. Outcome: The software achieved CE marking under MDR 2017/745 (Class IIb) within 18 months, supported by a robust technical file, Clinical Evaluation Report, and Post-Market Clinical Follow-Up plan.