Meet Obelis Responsible Person representatives at exhibitions
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Meet Obelis European Authorized representatives at exhibitions
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ISO 9001:2015 – A New Approach!
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After over three years of revision work and nearly 95 participating and observing countries, the new ISO 9001:2015 was published on September 23, 2015. This new approach has been released to respon [...]

BREXIT Explained!
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Brexit – What happened? On June 23rd 2016, 52% of UK citizens voted in favour of the ‘Brexit’: Britain-Exit of the European Union. This vote comes following much political disagreement, primari [...]

Obelis Scientific Department Officially Launched!
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On 1st September 2016, Obelis officially launched a new department within the company structure - the Scientific Department. It makes up part of the Compliancy Unit and complements the pre-existing R [...]

EROMED PPTs FOR SALE!

EROMED PPTs FOR SALE!

Obelis European Authorized Representative Center (O.E.A.R.C.) welcomes you to purchase your hard copy of the EROMED presentations: NEW EU Medical Device Regulation.

Single PPT: 50.00

Complete Booklet: 165.00

Presentations:

1) NEW Regulation Provisions
2) Clinical Evaluation
3) Labelling & Electronic Labelling
4) NEW Criteria to be met by Notified Bodies (Reg. 920/2013)
5) Unannounced visits by Notified Bodies
6) NEW obligations on EU importers/distributors
7) Impact on Authorized Representative (Mandate)
8) NEW PPE Regulation – impact on medical devices

 





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