Meet Obelis Responsible Person representatives at exhibitions
Event

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Meet Obelis European Authorized representatives at exhibitions
Event

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TTIP and SMEs: what potential?
News

The Transatlantic Trade and Investment Partnership (TTIP) has significant potential for small and medium sized enterprises, according to a report released by the European Commission. It presents the r [...]

ISO 9001:2015 – What You Need to Know
News

Why a new ISO 9001? All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. The future ISO 9001:2015 will respond [...]

non-medical-equipments
cosmetic-products

 

Obelis Group – EU Regulatory Consultants

 

Obelis European Authorized Representative Center (O.E.A.R.C) & Obelis European Responsible Person Center (O.E.R.P.C.) is a quality driven, service oriented company with over 25 years of experience with European Regulation. Obelis operates as one of the largest regulatory centers in Europe today, providing CE marking & Authorized Representative services for Medical Devices, In-Vitro Diagnostics as well as “EU Responsible Person” and Cosmetic Notification services in Europe.

Our services include: Product Classification; Authorized Representative & Responsible Person; Technical File & Product Information File; Notified Body Selection; Product Registrations; Labeling Compliance & Translations; GMDN codes; Free Sales Certificates; EU Trade Mark Submission; Environmental Regulations – REACh, RoHS & WEEE.