/ http://www.slideshare.net/images/logo.gif / 際際滷Share feed for 際際滷shows by User: karinebonenfant75 https://public.slidesharecdn.com/v2/images/profile-picture.png My main experience is in the field of Medical Devices: - Expertise in European regulation (Medical Devices Directive 93/42/EEC), - Knowledge of other regulations: Canada, USA, Australia / New Zealand, Taiwan, India, Brazil, China - Technical files for CE mark of class III and II medical devices - Preparation, management and review of international regulatory submissions for marketing clearances in domestic and international regulatory agencies - Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry - Control of product documentation and promotional material in compliance with the regulations - Control of the appl...