This is a recording of the March 14, 2018 webinar meeting.
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TOPIC: Post Market Surveillance and Post Market Clinical Follow up (PMS/PMCF) under MDR 2017/745
SPEAKER: Dr. Keith Morel
SPEAKER BIOGRAPHY: 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 Internal and External audit processes & execution, Management Review, QMS design & governance and the internal Training process. He was also 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 and performed more than 100 audits & 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 and he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification.
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 Ph. D. in Plasma Physics (Nuclear Fusion) and a First Class Honours degree in Physics from Imperial College of Science, Technology and Medicine, in the UK.