Mansour Consulting LLC

Mansour Consulting LLC is a Roswell, Georgia practice led by principal Jay Mansour. It supports medical device manufacturers with FDA pathway assessments, 510(k) submissions, responses to FDA observations, US-agent representation and quality systems aligned with 21 CFR Part 820 and ISO 13485. Its documented international work also includes CE-mark technical files, EU MDR and IVDR projects, EUDAMED support and Health Canada requirements.