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Obelis European Authorized Representative Center

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Obelis: More than 20 Years of Experience

Published 28 Dec 2008


Since 1988, Obelis has been providing head-on and custom made services to manufactures aiming at introducing their products onto the European market.

Launched in 1996, Obelis European Authorized Representative Center (O.E.A.R.C.) has been offering non-EU manufacturers the services of a European Authorized Representative / EU Responsible Person. These services are mandatory for such manufacturers but also gave them the support & guidance necessary to their product’ compliance with the new and ever-changing European Directives and Regulations. 

In 2003, with Obelis’ continuous efforts to strengthen the profession of Authorized Representation with the aim of ensuring the highest quality of service which will ultimately guide the market to safe & compliant products; Obelis was one of the founding members of the European Association of Authorized Representatives (E.A.A.R.) to operate under the MDD 93/42/EEC, the IVDD 98/79/EC and the AIMDD 90/385/EEC.

In 2005, Obelis broadened its international presence by opening a branch in Israel. This offered new opportunities for Israeli companies to expand their business and sell their products both locally and in the EU. 

In 2008, Dr. Peter N. Ruys joined the Obelis team as the Senior Regulatory Expert and non executive director. Ruys is also the founder of the Notified Body KEMA Quality (Medical Division) in the Netherlands and one of the leading members in the initial implementation of the European Directive for Medical Devices.

In 2008, Obelis celebrated a significant milestone of 20 years in business.

In 2009, Obelis extended its global presence even further by opening a branch in the United States. This expansion helped Obelis develop into one of the largest regulatory centers in Europe.

In 2010, Obelis was fortunate to welcome Mr. John L. Webster as yet another addition to Obelis’ team of experts. Mr. Webster adds over thirty years of quality assurance, regulatory and management experience to the team.

In 2010, Obelis strengthened its worldwide presence further on through the creation of Obelis International Offices (O.I.O.). Experts around the world, providing quality services and personalized solutions to the complex regulatory requirements in their respective markets while performing the dedicated role of Obelis’ Official Representative Office in the local markets.

In 2011, Obelis helped institute the European Responsible Person Association (E.R.P.A.) to once again strengthen the profession of EU Responsible Person for Cosmetic products and ensure the quality of service by such service providers – as such, aiming at introducing safe & compliant products onto the European Market under the EC 1223/2009.

Throughout its history Obelis has continued to grow in expertise, knowledge and experience with a clear understanding that only through education and understanding compliance will be achieved and safe products will be introduced. With over 20 years in the profession, Obelis plans to constantly improve and continue to serve its clients as one of the most professional and largest regulatory centers in Europe. 



Obelis achievements over the Years…

  • 1988 : Creation of Obelis
  • 1992 : Obelis launching of the European Front Office (E.F.O.)
  • 1996 : Obelis launching of the “European Authorized Representative Center” (O.E.A.R.C.) 
  • 1998 : Obelis launching of the Internship Program (O.I.P.)
  • 2003 : Obelis as a founding member of the European Association of Authorized Representatives (E.A.A.R.)
  • 2003 : Creation of OneLink OneSolution (O.L.O.S.)
  • 2005 : Opening of Israeli Branch
  • 2006 : Creation of the “Obelis Group”
  • 2008 : Dr. Peter N. Ruys assigned as Obelis’ Senior Regulatory Expert and non executive director
  • 2008 : Creation of GiDoS s.p.r.l.
  • 2008 : Milestone – 20 years in business!
  • 2009 : New management chart including new notification department
  • 2009 : New services for Food Supplements and Biocides
  • 2009 : Opening of USA branch
  • 2010 : Creation of Obelis legal department
  • 2010:  Mr. John L. Webster joins Obelis Team of Experts
  • 2010 : Creation of Obelis International Offices (O.I.O.)
  • 2010 : Launch of 1st O.I.O. Convention
  • 2010 : Launch of EROMED and ECORE seminars
  • 2011 : Obelis as a founding member of the European Responsible Person Association (E.R.P.A.)

 

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