Consultants | Jay Mansour
Mr. Jay Mansour is a regulatory consultant working with FDAimports.com, LLC, concentrating on medical device 510(k) submissions, quality system development in accordance with FDA and ISO 9001/13485, auditing and validations, as well as CE marking.
Mr. Mansour has been in the product quality control and assurance arena for over 20 years, and he has been exclusively dedicated for the medical device industry since 1997.
Mr. Mansour holds a Masters Degree in Quality Assurance and a Bachelors degree in Engineering. He is regulatory affairs certified (RAC) by Regulatory Affairs Professional Society (RAPS).
Mr. Mansour has taught masters level college courses in quality systems course as assistant professor and has been a quality systems auditor. He has successfully managed numerous FDA inspections and has filed many successful 510(k) applications, including for FDAImports.com, LLC clients.
Mr. Mansour currently assists many U.S. and non U.S. companies in various aspects of FDA regulations for medical devices, including filing and successfully prosecuting 510(k) submissions and conducting early product evaluations, ISO certifications (9001/13485), CE marking, quality systems development, process validations, and auditing to FDA’s Quality System Regulations (QSRs). He also assists in device prototyping, coordinating various laboratory tests (such as biocompatibility and Electrical Safety), as well as manufacturing assistance, including outsourcing and subcontracting.