Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"
Mr. Webster managed MDCI Ltds medical device consulting and European Authorised Representative business in the UK from 1997 until 2010. He has over 40 years of quality assurance, regulatory and management experience.
Mr. Webster served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. based in UK.
During the writing of the Medical Device Directive, he was responsible for technical affairs at EUCOMED representing the medical technology industry in Europe, and chaired the committee writing the Essential Requirements in Annex I of the Directive. Mr Webster has chaired the committee responsible for writing the European standards on labelling and symbols used with medical devices (CEN/CLC/TC 3/WG 1) since its creation. He regularly speaks at professional conferences on all aspects of medical device quality and regulatory compliance
He holds a higher degree in Chemistry from the University of Newcastle upon Tyne, is a Chartered Chemist and a member of the Royal Society of Chemistry (C.Chem, M.R.S.C.), holds a Diploma in Management Studies from the University of East Anglia, is Certified as a Quality Engineer by the American Society of Quality, is a Fellow of the Regulatory Affairs Professional Society (RAPS), serves on the European Operating Committee and is Regulatory Affairs Certified (RAC).
John Webster has acted as Treasurer of the European Association of Authorised Representatives (EAAR) and currently holds the post of Secretary.