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 [...]

European Parliament Rejects the Inclusion of Health in the TTIP Talks
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On April 14th 2015 Members of the Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) approved an Opinion on recommendations to the European Commission on the negotiations [...]

TTIP and SMEs: what potential?
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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 [...]

Meet Obelis European Authorized representatives at exhibitions
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Meet Obelis Responsible Person representatives at exhibitions
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non-medical-equipments
cosmetic-products

 

Obelis Group – EU Regulatory Consultants

Obelis Group is a quality driven, service oriented company, based in Brussels, Belgium. Founded in 1988, today Obelis operates one of the largest regulatory centers in Europe, providing CE marking & Authorized Representative services for Medical Devices, In-Vitro Diagnostics and other product types (Personal Protective, Machinery, Toys, Pressure Equipments, etc) as well as “EU Responsible Person” and Cosmetic Notification services towards product launch in the European Economic Area (EEA).

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.