John L. Webster, Independent Consultant to the healthcare industry. He has worked in the medical devices and associated industries with four multinational organisations, and as a consultant for the last 40 years with responsibility for quality assurance, quality control and regulatory affairs. He has been based in Ireland, Belgium, France, USA and UK. He was Technical Director for EUCOMED during the time the Medical Device Directives were being written, is recognised as an Expert in Medical Devices by the European Commission and is chairman of the European Standards committee on labelling and symbols to be used for Medical Devices (CEN/CLC/TC3/WG1). He is also active in several other national and international initiatives relating to Medical Devices.Mr Webster can be contacted on Tel: +44 7802 30 80 92John@JLWebster.com

Medical device and IVD Classification, Technical Documentation, Vigilance, Quality Systems, Project Management, Seminar Presentations

Medical Device and IVD Consulting, Authorised Representative, Technical Documentation, Quality Systems, Vigilance, Seminar Presentations.

Medical Devices, Preparation and European Regulatory submissions, Quality Systems, Overseeing the Quality Operations in the European Manufacturing locations, working with Competent Authorities and Notified Bodies to implement the Medical Device Directive...

Chair the Committee negotiating and implementing the Medical Device Directive with the European Commission and Regulators on behalf if European industry. Participated in and oversaw the activities of the various working groups, chaired the Labelling Committee, chaired the CEN Working Group responsible for Medical Device Symbols and Information Supplied.

Regulatory submissions, customer complaint handling, working with European manufacturing facilities on quality issues.