EROMED, held on 24 May 2010, in Sao Paulo, Brazil was a great success thanks to our cooperation with EG MONT of Brazil, and HI-POWER, a Brazilian company representing the Czech Notified Body ITC in Brazil.
The workshop involved over 40 participants, including a representative of ABIMO, the Brazilian Association of Medical Devices Manufacturers .
EROMED was a 2 day event including multiple workshops dedicated to informing our clients and collaborators about the NEW European regulation imposed by the 2007/47/EC. Each workshop focuses on teachings by experts about the latest developments in the European Regulatory framework concerning Medical Devices in reference to 2007/47/EC.
The EROMED workshops are prepared to inform local importers and manufacturers that wish to obtain the CE marking in order to meet European standards. We invite all Chief Executive Officers, Quality Assurance Managers, Regulatory Affairs Managers, Export Managers, and Certification Managers of our clients and associates clients.
The aim of our seminars are to present the European Regulation on Medical Devices in accordance with the MDD 93/42/EEC and its amendment, the 2007/47/EC. We place an emphasis on the new revision in Europe and its implications and implementations.
Specific training included 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
The workshops were well attended, very informative and wondrefully presented.
Thank you to EGMONT and Eduardo Monteiro for a wonderful time in Brazil.
We applaud the success of all that participated!
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