Medicept
Principal Software Quality Engineer
Gregg Van Citters has over 18 years of experience in the medical device industry. He has broad experience in QMS development and implementation, including compliance to EU MDR/IVDR, ISO 14971, IEC 62304/82304, IEC 81001-5-1, IEC 60601, and IEC 62366. He has assisted clients in developing compliant Quality Management Systems, delivers QMS training, and is an experienced Quality Management System auditor. He focuses on design quality engineering, including software engineering, threat modeling and cybersecurity, human factors engineering, and safety risk management.
As a Principal Software Quality Engineer at MEDIcept, Gregg is responsible for leading teams supporting client system and software projects from concept development and security lifecycle planning through verification and validation testing. He supports client needs including usability engineering, security and safety risk management throughout the development lifecycle. He has also performed mock FDA audit and QMS health assessments for MEDIcept clients.
Before joining MEDIcept, Gregg worked as a systems engineer for various Class II/Class III medical and in vitro diagnostic device manufacturers, and as an independent quality and engineering consultant. Throughout his career, Gregg has held various positions including software engineer, research professor, clinical research trainer, Lean/Six Sigma Black Belt, and quality systems manager.
Gregg holds B.S. degrees in Chemistry and Mathematics from Norwich University; an M.S. degree in Human Nutrition from California Polytechnic University Pomona and a Ph.D. from University of Southern California. He is a member of ASQ, including the Biomedical Division and the Los Angeles group, and RAPS. He has held various volunteer leadership positions with community groups including Toastmasters International, Association for Talent Development (formerly ASTD), and the California Dietetic Association. He is the coauthor of numerous original research articles, review papers and book chapters in nutrition, gastroenterology and diabetes.