The Latest EU Regulatory Developments
The new directive 2007/47/EC has implications not only for manufacturers who sell medical devices in the EU but for the medical device industry as a whole. More ».
CE Marking
The European Commission describes CE marking as a "Passport to Europe" which allows manufacturers to freely circulate their products within the European market. CE Marking is now mandatory for a wide range of products sold within the European Union... more »
CE - FAQ
What is CE marking?
CE marking means a mark is being placed on products by their manufacturer acting as a statement that the product meets all the standards and requirements of the relevant legislation according to the appropriate European Directives. CE Marking gives companies access into the European market to sell their products without adaptation or rechecking...more »
Non-European Manufacturers
If you are a medical device manufacturer located outside the European Union or the European Free Trade Association and wish to export into the European Market, you must follow several steps to ensure that your product is in compliance with the European Directives... more »
Appointing European Authorized Representative
There are many details to consider before appointing your European Authorized
Representative
more »
Update Medical Devices Directive 93/42/EEC - Clinical Evaluation
In reference to the recent changes to the MDD 93/42/EEC by its amendment the 2007/47/EC, the following needs to be brought to your attention
more »
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Medical Device Directive Workshop in Sao Paulo, Brazil
In reference to the expected changes in the European Directives, Obelis and EG Mont Assessoria e Consultoria Ltda. have initiated a workshop in Sao Paulo, Brazil which will focus on these changes and their implications. read more »
CD of Essential Requirements for MDD & MSD
As a foundation for the implementation of the expected amendments within European Directives, Obelis has created a CD containing valuable information which will assist in the implementation of these Directives. read more »
Italy Registration
Placing your product into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). read more »
Medical Device Directive Seminar in Tel Aviv, Israel
In reference to the expected changes in the European Directives, Obelis has initiated a seminar in Tel Aviv, Israel which will focus on the latest changes in European Directives for Medical Devices and the new implementations in European “Green” regulation. read more »
O.E.A.R.C.Medical Device Exhibition Participation
Obelis European Authorized Representative is proud to announce its participation in the worlds most important medical device exhibitions
Featured:
 Obelis is excited to announce the latest OneLink OneSolution advancement. While still retaining the core group of international compliance experts, OneLink OneSolution will begin the process of expanding its boundaries beyond the current service offerings which include regulatory services, language compliance solutions, and new market penetration assistance companies.
OneLink OneSolution will now include businesses from a variety of fields, including marketing, distribution services, public relations, technical writing, and internet marketing. These companies will be carefully selected to ensure they maintain the same superior standard as current OneLink OneSolution members .... |
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