Obelis Group is a leading specialist in European regulatory, directive, and compliance strategy. Its CE marking, responsible person, authorized representative, and consultancy services have helped countless European and non-European manufacturers alike introduce products successfully to the EU market.
Founded in 1988, the Obelis Group of companies (including Obelis European Authorized Representatives Center and Obelis European Responsible Person Center) operate as one of the largest regulatory and compliance centers in Europe. It is also a veteran member of the EAAR (European Association of Authorized Representatives) and a founding member of the ERPA (European Cosmetics Responsible Person Association).
Medical & In-Vitro Devices
As an EU leader in healthcare device regulation, Obelis offers full Authorized Representative services as well as consultancy and guidance on: MDR & IVDR, technical file creation and review, EUDAMED registration, UK representation, IVD notification, Notified Body selection, market notification and vigilance, product classification, free sales certificates, identification of standards and essential requirements, risk management, CE marking, clinical evidence, and trade mark submissions, national device registration.
Full EU Compliance
Obelis services cover many of the New Approach European Directives (those making CE marking or an authorized representative mandatory for products). Obelis is a market expert in CE marking and compliance for machinery, personal protective equipment, pressure equipment, radio and telecommunications equipment, electrical equipment, low voltage equipment, and toys, with a strong emphasis on cosmetics and medical and in-vitro devices.
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