EU Authorised Representative service enabling medical device manufacturers and importers to demonstrate regulatory compliance with EU MDR/IVDR requirements. Provides expert guidance on EU, UK, US, and Swiss regulatory pathways for medical devices, in vitro diagnostics, and cosmetic products. Facilit...
Manufactured by
Obelis Group S.A.
Brussels, Belgium
Global Regulatory Compliance - Your Authorized Representative Responsible Person WE SUPPORT MANUFACTURERS OF MEDICAL DEVICES IVDs Obelis is a quality-driven, service-oriented regulatory affairs company located in Brussels, Belgium. At Obelis, we specialize in ensuring regulatory compliance for Medical Devices, and other industries. Our Authorized Representative services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US and Switzerland, and beyond to support your compliance needs effectively. WE REGISTER YOUR PRODUCTS IN THE EU, UK, US SWITZERLAND. Our Solutions Authorised Representation (EC REP) /Responsible Person (UK RP)/ Swiss Authorised Representative (CH-REP) EUDAMED device and actor registration Device registrations to the EU, Swiss UK Authorities (MHRA) MedDO/IvD and comprehensive regulatory documentation services.
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