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Obelis — Your Consultant on EU Regulation
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EU Representation

Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the entire community.

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EU Product Registration

Ensuring compliance and registering products to be made available on the EU Market.

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Technical Documentation Review & EU Submissions

For your products to legally enter the EU Market and continue to circulate, you must have valid documentation.

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EU Consultancy, Legal & Training

Find your way through a complicated EU marketplace with the support of a professional.

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              About Us

              Back in 1988, our CEO Mr. Gideon Elkayam founded Obelis: a small, family-run business with a grand vision to “create compliance for safer markets”.

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              Careers at Obelis

              Take the first step to a consulting career that helps build a safer Europe.

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              The Team

              Meet the dynamic team creating compliance for safer European markets.

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              Testimonials

              We have provided compliance and consulting services for more than 3000 manufacturers in over 60 countries, helping them successfully introduce products to the European market.

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              Contact Us

              Our head office is in Brussels and we have a network of offices in 11 different countries including the US and Israel.

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              International Representatives

              An experienced EU compliance representative is just a call or meeting away…

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              Obelis International Offices (OIO) Network

              Obelis International Offices are independent partners who are able to provide our clients with solutions in other global markets of their choosing.

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              Obelis — Your Consultant on EU Regulation
              1. Home
              2. Blog
              3. Healthcare & Medical Devices

              Blog: Healthcare & Medical Devices

              Brexit, what about UK-EU Trade?

              05 October 2020

              Regulatory requirements for medical face masks – European Commission Guidance

              06 August 2020

              Free Sales Certificates needed for medical device registration in Bosnia and Serbia

              06 August 2020

              Personal protective Equipment and Medical Devices in the Covid-19 context –how can they be lawfully placed on the EU market?

              06 July 2020

              How is protective clothing regulated in the EU?

              20 April 2020

              Do you want to place your 3D printed product on the EU internal market to be used in a medical context and fight against COVID-19?

              03 April 2020

              Formula for implementing MDR

              24 March 2020

              Catch a glimpse of proposed symbology under the MDR!

              18 February 2020

              Parallel trade under the MDR

              17 February 2020

              EUDAMED POSTPONED, CONSEQUENCES FOR COMPLIANCE?

              13 February 2020

              SWEXIT OR NEW MRA?

              12 February 2020

              Person Responsible for Regulatory Compliance. A star is born!

              04 July 2019
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