Medical Devices Workshop in Sao Paulo by EG Mont & Obelis
With a collaboration of over a decade, OBELIS and its Representative in Brazil, EG MONT, are proud to launch a resourceful workshop on the 23rd of May, 2012 in Sao Paulo.
As a special support to manufacturers exhibiting or visiting Hospitalar 2012 the Workshop will cover current issues and processes on the implementation of EU directives, EU harmonized standards and detailed steps to be taken by manufacturers in order to attain the CE marking affixed on their medical devices.
Already at its 6th edition, this insightful workshop has proven to be a strategic move for a many professionals in several domains within the medical device industry looking to further expand their business to the European Market and other international markets by having their products CE certified.
The workshop will cover critical topics, such as:
- Role of the Notified Bodies ;
- Role of the European Authorized Representative ;
- Medical Device classification and Declaration of Conformity;
- National Device Registrations ( Italy, Portugal & France);
- GMDN code verification;
- The new MEDDEV 2.5/10 – guidance document on the Authorized Representative;
- Free Sales Certificate by a European Authority;