Diane Keyser

Diane has over 30 years of broad experience in the development of medical devices, encompassing early-stage concept through high-volume manufacturing with start-ups through Fortune 500 companies. As both an individual contributor and manager of teams of engineers, she has worked on hundreds of products that aim to provide solutions to previously unmet needs. As a quality professional, she was directly responsible for the development and maintenance of a Quality Management System (QMS) from the ground up. She appreciates the importance of robust design control and risk management documentation to support regulatory submissions. Diane holds a M.S. in Mechanical Engineering from Stanford University and a B.S. in Mechanical Engineering from MIT. She is a certified ISO 13485:2016 Lead Auditor.