European Authorized Representative Center & CE Marking Consultants

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ISO 9001:2001
ISO 9001:2001
CE Marking

European Authorized Representative CE Marking Consultants

Obelis European Authorized Representative Center (O.E.A.R.C.) provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives such as MDD 93/42/EEC, IVD 98/79/EC, and Low Voltage Devices 73/23/EEC. Our high quality compliance solutions, proven by our ISO 9001:2001 certification, include Commercial, Regulatory, Administrative, and Market Development Services through our Brussels, Belgium headquarters. Our worldwide regulatory solutions are provided through our global and professional One Link One Solution™ Network. We will help you get to the next level.

 

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 »


Medical Device Directive Seminar in Tel Aviv, Israel

In reference to the expected changes in the European Directives, Obelis initiated a seminar in Tel Aviv at the Israeli Export Institute on June 22nd 2008. The seminar was a great success with over 50 participants in attendance.
more »


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.
more »


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 ....

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

arab health kenes biomed medica exhibition 2007

Obelis 20th Anniversary

obelis 20 yr anniversary

It is with great pleasure that we announce the 20th Anniversary of Obelis s.a. Read more


Launching Gidos s.p.r.l- Green Regulatory Center

obelis 20 yr anniversary

We are pleased to announce the launching of Gidos s.p.r.l -Green Regulatory Center. Gidos will deal solely with matters pertaining to the compliance with the European Green Directives and Regulations and will be fully operational as of September 1st 2008 Read more

(EC) REACH 2006/1907

REACH is the regulation for Registration, Evaluation, Authorization (and Restriction) of Chemicals. The regulation places greater responsibility on the industry to manage the risks chemicals may pose to health and the environment. Read more

WEEE 2002/96/EC & 2003/108/EC

The "Waste Electrical and Electronic Equipment" Directive promotes the recycling of Electrical and Electronic Equipment (EEE) and their components at end-of-life or when being replaced. Environmentally responsible practices are encouraged among all those who are involved in the life cycle of EEE. Read more

RoHS 2002/95/EC

The Restriction of the use of certain Hazardous Substances specifies maximum levels for use of 6 restricted hazardous substances in the manufacture of various types of Electrical and Electronic Equipment (EEE). RoHS coincides with the WEEE Directive as part of a legislative initiative to solve the problems and risks associated with large amounts of electric waste. Read more

Free Sales Certificate

Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within that specific country. 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 »



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