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.