VP Regulatory Compliance
Qserve Group
Dr. Keith Morel is Scientific Lead of the Medical Device Business Unit, VP of Regulatory Compliance & Principal Consultant at Qserve Group, one of the largest European-based medical device consulting companies.
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).
Keith was also a Senior Project Manager for DEKRA Certification for 9 years. During his time at DEKRA he was a quality system and regulatory lead auditor, as well as a design dossier reviewer. He performed more than 100 audits and 200 Design Dossier/Technical File reviews.
Before DEKRA, Keith worked in R&D in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products. He holds both a First-Class degree and a Ph.D. in Physics from Imperial College of Science, Technology and Medicine, in London.
In his spare time, Keith is an Adjunct Assistant Professor in the USC Regulatory Sciences program, teaching classes on (among others) Risk Management, SPC/Medical Product Quality, EU MDR and Standards.
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Post-Market Surveillance under MDR and IVDR: Practical Insights Where Efficiency Meets Compliance
Thursday, October 24, 2024
11:45 AM - 12:45 PM CEST