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.