Obelis launches “EROMED” Workshop
DO NOT MISS OUT ON THIS YEAR’S SESSION :
“Spring 2010 Deadline : 2007/47/EC provisions and implementations on Medical Devices”
Workshop Dates:
– Tuesday 20th October 2009 8:30am to 6:00pm
– Wednesday 21st October 2009 8:30am to 6:00pm
The Aim of the Seminar
To present the European Regulation on Medical Devices in accordance with the MDD 93/42/EEC and its amendment the 2007/47/EC with an emphasis on the implications and implementations of the new revisions to be in full force as of 21 March 2010.
Target Audience:
Organizations
– Local Importers who wish to export to Europe
– Local Manufacturers who wish to meet European standards and eventually Export to Europe
Executives
– Chief Executive Officers
– Quality Assurance/Regulatory Affairs Managers
– Export Managers
– Certification Managers
Training will consist of, among other things, the following topics:
• Essential changes in the Medical Device Directive 93/42/EEC by the 2007/47/EC
• Notified Body approach to the revised Medical Device Directive 2007/47/EC
• Authorized Representative definition, role & duties: comparative analysis
• Technical documentation
• EU Member State National Requirements for Medical Devices
• Impact of the Machinery Directive on Medical Devices
• RoHS 2002/95/EC Recast – implications on Medical Devices
Opening remarks of the workshop will be made by Dr. Nadav Shefer of the Israeli Ministry of Health – Medical Device Department Director