Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"
For details and registration (Download the invitation in English) CLICK HERE
(Download in Portuguese) CLICK HERE
Feel free to contact us or Obelis’ Brazilian affiliate EG Mont
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EROMED is a 2 day workshop exclusively dedicated to the NEW European regulation imposed by the 2007/47/EC. The workshop will take place in Sao Paulo, Brazil in conjunction with the international medical exhibition Hospitalar.
EROMED is organized by Obelis s.a, European Authorized Representative Center & GiDoS sprl in association with ITC, a Czech Notified Body and EG Mont from Brazil. Participants will be taught by experts in their fields regarding the latest developments in the European Regulatory framework concerning Medical Devices in reference to the new amendment to the MDD 93/42/EEC, the 2007/47/EC.
DO NOT MISS OUT ON THIS YEAR’S SESSION :
“2007/47/EC. provisions and implementations on Medical Devices”
Workshop Dates:
- Tuesday 25th of May 2009 8:00am to 12:00pm
- Wednesday 26th of May 2009 8:00am to 12:00pm
The Aim of the Seminar
To provide a practical understanding of the European Regulation on Medical Devices in accordance with the MDD 93/42/EECand its amendment the Medical Device Directive 2007/47/EC. with an emphasis on the implications and implementations of the new revisions in Europe.
Target Audience:
Organizations
- Local Manufacturers who wish to meet European standards and eventually Export to Europe
- Local Importers who wish to 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 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
• 2007/47/EC. on MDD class I devices – Compliance route to market
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For details and registration (Download the invitation in English) CLICK HERE
(Download in Portuguese) CLICK HERE
Feel free to contact us or Obelis’ Brazilian affiliate EG Mont
Last updated Apr 01, 2010
Contact us now to find out more.