Regulatory consulting service for appointing UK Responsible Persons for medical devices and in vitro diagnostics. Supports manufacturers with MHRA registration, technical documentation preparation, conformity assessment, and UK MDR compliance to achieve market authorization.
Manufactured by
Maven Profcon Services LLP
Ahmedabad, India
We are a medical and IVD device regulatory consultancy that was established in 2016 and ever since we have been offering a wide array of services to the medical device fraternity to meet their regulatory needs. Our services include both holistic and customized solutions where we provide clients with end-to-end support for their certification requirements and also offer customized support if they are looking for specific documentation/services support instead of an entire submission. Our services include but are not limited to - CE - USFDA - UKCA - ISO 13485 - MDSAP - 21 CFR Part 820 - Clinical Trials - Country Registrations - Authorised Representative services (EC REP, UKRP, US agent, Swiss Rep) - UDI support - Annual Maintenance Services - Premium Organisational Maintenance Services - Clinical Evaluation writing and many more We have assisted more than 350 manufacturers with various certification requirements and our clients are based all around the globe.
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EUCEREP B.V. · Netherlands
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.
Obelis Group S.A. · Belgium
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.
MedNet EC-REP GmbH · Germany
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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