UK Responsible Person designation and regulatory compliance service for medical devices and in vitro diagnostics entering the UK market. Ensures manufacturers meet UK MDR and IVDR post-Brexit requirements, including technical file preparation, quality management oversight, and regulatory submissions...
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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UK Responsible Person (UKRP) representation service for medical devices and IVDs seeking market authorization in the United Kingdom. Ensures regulatory compliance with UK MDR requirements and facilitates in-country representation for non-UK established manufacturers.
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Regulatory representation service enabling medical device manufacturers to market products in the UK under the Medical Devices Regulations. The service manages post-market surveillance, technical documentation, and compliance obligations for Class I through Class III devices, allowing manufacturers to distribute products without establishing a UK legal entity.
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UK Responsible Person regulatory representation service enabling non-EU medical device manufacturers to achieve compliant market access in the UK. Encompasses MHRA registration, technical documentation support, Quality Management System establishment, and ongoing regulatory compliance guidance.
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