CAMPOMATS

Mansour Consulting LLC is a specialized regulatory consulting firm serving medical device manufacturers since 2000. Based in Roswell, Georgia, the firm provides comprehensive regulatory solutions spanning FDA 510(k) strategy, ISO 13485 and 21 CFR Part 820 quality systems implementation, UDI/GUDID/EUDAMED compliance, FDA representation (US Agent and Official Correspondent services), technical assistance with R&D and lab testing coordination, and medical device classification/pathway assessment. The firm also develops and markets an integrated compliance software platform combining ERP, document management (DMS), learning management (LMS), labeling, and UDI tools—purpose-built for small to mid-sized medical device manufacturers. With over 30 years of industry experience, the principal provides direct senior-level engagement across the full product lifecycle from pre-market strategy through postmarket surveillance, with regulatory expertise spanning US FDA, EU MDR/IVDR, and Health Canada requirements.