Obelis Obtains ISO 13485:2003 Certification

In addition to the ISO 9001:2008 certificate obtained since May 2001, Obelis European Authorized Representatives Center (O.E.A.R.C.) has obtained its ISO 13485:2003 certification in April 2012, attesting to the high level of quality services provided to its clients.

ISO 13485:2003 sets prerequisites for quality management systems, evidence to a company’s capacity to manufacturer medical devices and/or provide related services aimed at consistently meeting customer and regulatory requirements.

This certificate, presents conformity of Obelis’ Quality Management System to the EN/ISO Standard 13485:2003 in reference to Authorized Representative services and other consulting activities related to medical devices under the MDD 93/42/EEC, AIMDD 90/385/EEC, IVDD 98/79/EEC and other EC Directives & Regulations applicable to medical devices.

This certification provides an additional indication towards Obelis’ services in reference to one of the most important standards in Europe today, aimed at medical devices, thus reflecting a quality assurance to Obelis’ ability to:

  • Appropriately handle all client related information & regulatory activities within the European Market;
  • Deliver the support & advice required in reference to conformity with the EC Directives & Regulations applicable to medical devices;
  • Foremost, fulfill the responsibilities, obligations & services of a professional European Authorized Representatives.
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