Sam Mostafavi, MS, MBA

Sam Mostafavi, MS, MBA

Senior Consultant

Mr. Mostafavi joined Biologics Consulting in August 2018 and has over twenty years of drug/medical device industry expertise, including twelve years of management experience at various organizations. He has direct experience in product and software development lifecycle from concept to commercialization, including design development, regulatory strategy, authoring of regulatory submissions, study planning, quality system, manufacturing, and post market surveillance. Mr. Mostafavi also has experience in international regulatory approval and production setup and qualification.

Mr. Mostafavi previously worked for Conavi Medical as Head of Quality and Regulatory implementing a quality management system compliant with ISO 13485, as well as obtaining CE Mark, Health Canada MDEL, and FDA clearances.

Prior to Conavi, he worked for Vital Connect as Vice President of Quality and Regulatory. In this role, he authored and implemented a full quality system, coordinated non-clinical study, and internal product and software testing, managed external product testing, authored and obtained FDA clearance, CE and Health Canada approval. Additionally, worked on the PMDA strategy and approval.

Mr. Mostafavi serves as the U.S. Agent Representative for several products. As U.S. Agent, Mr. Mostafavi interfaces with CDRH and attends FDA-Sponsor meetings as needed. he is familiar with FDA regulations and guidance, as well as policies and procedures at CDRH.

Mr. Mostafavi has extensive experience in product and software development lifecycle and regulatory submission. He has provided training in these areas at several Medical Devices companies in United States and Internationally.

Mr. Mostafavi has received B.S. in Electrical Engineering, Master of Science in Computer, as well as MBA from Old Dominion University.


Education

MBA, Old Dominion University, Norfolk, VA

MS, Computer Science, Clayton University, Morrow, GA

BS, Electrical Engineering, Texas A&M University, College Station, TX