Obelis Group

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HOME TITLE: CE Marking, EU Regulatory Consulting and EAR Services DESCRIPTION: Medical, cosmetic, or other products intended for sale in Europe? We provide the compliance consulting & representative services you need to make it happen… Option 1 Helping your organization innovate and expand into safer European markets Option 2 Your authorized partner for innovation & expansion into safer European markets Option 3 Your trusted advisors for innovation & expansion into safer European markets Option 4 Your trusted partners for introducing life-changing products to European markets ⦁ Introduce life-changing products to Europe with the help of our 30 years’ experience ⦁ CE marking & representative services to ease approval of medical devices, cosmetics & other products ⦁ Regulatory & compliance consulting makes life easier for non-European manufacturers ⦁ Consulting for European innovators to achieve compliance with Horizon 2020 projects Start working on bringing your products to Europe [GET IN TOUCH] Insert trust badges (professional certifications/awards) etc. Insert some key statistics here…examples: With over 30 years’ experience Helping over 500 companies In over 30 countries Open up the European market with a trusted partner Medical devices We can help smooth the way for your medical devices to enter European markets safely and compliantly: European Authorized Representative services, CE marking, and regulatory and compliance consulting. Cosmetics We can help your cosmetic products successfully enter the European Economic Area with our European Responsible Person, CE marking and compliance consulting services. CE Marking Not in the medical sector but still aiming to enter the European market with your products? Achieve that with the help of our CE marking advisory and regulatory consulting services. Horizon 2020 Are you a start-up or innovator working on a project with Horizon 2020 funding and in need of assistance with meeting Europe’s strict regulatory standards? We can help… Who are we? Based in Brussels since 1988, Obelis helps the world’s most innovative and committed organizations bring life-changing products to the European Economic area. Whether it’s a medical device, cosmetic product, or other item, if it improves the lives of Europeans, we want to help you bring it here safely with regulatory and compliance consulting services that you can rely on. FIND OUT MORE… Who’s it for? Do you manufacture or distribute: ⦁ Medical devices that you want to make available for sale in the European Economic Area? ⦁ Cosmetic products that you want to bring to Europe? ⦁ Other products intended for sale in Europe? Achieving approval for sale on the European market can involve a regulatory maze that requires experienced and professional assistance to navigate. Most small and medium-sized organizations don’t possess the necessary know-how in-house. So we need to talk… Why Obelis? ⦁ Experience in dealing with EU regulatory bodies since 1988 ⦁ Full focus on regulatory compliance with no conflicts of interest ⦁ Experience in dealing with sensitive, unforeseen or complex regulatory problems ⦁ In-depth knowledge of national laws across EU member states ⦁ Confidentiality for all your sensitive information and documentation ⦁ A strong presence across the EU and internationally, with multilingual representatives ⦁ Compliance with ISO 13485 and ISO 9001 ⦁ An open communication channel - to keep you informed of progress every step of the way “Obelis is the sixth consulting firm we have worked with and NONE can compare with the professionalism and knowledge your team exhibits.” Medical Device (MDD) manufacturer (USA) [GET IN TOUCH]