Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations.
He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer) where he was responsible for the Internal and External audit processes, Management Review, QMS design & governance and the internal Training process.
Dr. Morel was a Senior Project Manager for DEKRA Certification Inc. for 9 years. During his time at DEKRA, he was lead auditor for CE (MDD) & 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, as well as a drug-device combination product expert.
Dr. Morel has also worked in R&D in the Medical Device industry in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products. He has both a PhD in Plasma Physics (Nuclear Fusion) and a First-Class degree in Physics from Imperial College of Science, Technology and Medicine, in the UK. In addition, he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification. Keith.Morel@Qservegroup.com