Instructor

Keith M Morel LinkedIn

KEITH MOREL, Ph.D., is vice president/U.S. team manager of regulatory compliance at Qserve Group, the largest EU-based medical device consulting company focused on medical devices and in vitro diagnostics. Since 2000, he has helped both startups and multinational companies work through MDR compliance projects. Previously he was senior director of regulatory compliance at Accuray, a radiation oncology medical device manufacturer, and senior project manager for DEKRA Certification. where he was lead auditor for European conformity for medical devices directive (CE MDD) and ISO 13485:2003. While there, he performed more than 100 audits and more than 200 design dossier/technical file reviews. He was also DEKRA’s senior cardiovascular product expert and a drug device combination product expert. Working in R&D as as engineer, manager and director, he has worked on technologies such as Intravascular ultrasound catheters and super-oxidized water products. He has a doctorate in plasma physics and a first class (bachelor’s degree equivalent) in physics from U.K.-based Imperial College of Science, Technology and Medicine. He is certified as an ASQ biomedical auditor and a CMDCAS auditor.