Obelis is delighted to announce its new expert groups on Linkedin!
For our team of professionals in Obelis, Linkedin is more than just a social media platform that helps connecting people. It goes beyond that. Linkedin offers a higher added value through letting users gain know-how, share information or even consult with each other. It offers a platform for real professionalism. Therefore, it not only connects people it connects people within specialized areas, such as the one on medical devices, in-vitro diagnosis medical devices & cosmetics.
The regulatory framework of Medical Devices &Cosmetic Regulation in the European Economic Area might seem to be an impenetrable maze at first sight. It is indeed complex but conformity is only but a process which requires each new product to be treated as a project, create a plan and follow it through.
As part of Obelis' commitment, for over 20 years now, to education and placement of high quality & safe products onto the European market, Obelis envisaged different tools to ease manufacturer's road to conformity and market entry - Professional Groups on LinkedIn serve as excellent tools.
Our professional groups aimed at helping European & non-European manufacturers to share their views, difficulties and successes while operating on the EU market, provide hands on insight to those in need of guidance and support or simply have a concern to relieve themselves of. All groups are open to join for professionals, manufacturers and anyone, whose aim is to understand and comply with European regulation.
Choose the one that suits your needs the most!
• European Authorized Representative
Are you a Non-European manufacturer and wish to sell your products in the European market? Do you want to make sure your products are compliant with European regulations? Join this group to find out what are the requirements for entering the EU market, which a professional Authorized Representative/EC Rep can provide!
• Medical Device Directive
Is your product intended to be used specifically on human beings for the purpose of diagnosing, treating, preventing, monitoring, or alleviating a person's condition as well as in conjunction with those who are injured or handicap and you aim at obtaining the CE marking? If so, you probably seek compliance with the Medical Device Directive!
• PIF & Cosmetic Notification
Are you a Manufacturer of cosmetic products? Are you planning to penetrate the European Market but still have many questions in regards to this process? You might already be selling your products but still unsure if you comply with the requirements of the EU Cosmetic Regualtion? If you answered 'yes' to any of the above questions, then this group is for you!
• European Cosmetic Responsible Person
A professional group primarily, but not exclusively, created for non-European Manufacturers of cosmetic products which are required by EU Law to designate by legal mandate an EU Responsible Person established within the European Union while European manufacturers may choose to do so. Join today and find out what is required of you in order to be able to sell your cosmetic products in the European Economic Area!
• Registration of Medical Devices in Europe
A professional group of experts aimed at assisting European & non-European manufacturers through the national device registration procedures imposed by Italy, France, Portugal, Latvia, Greece and others on Medical Devices!
• EU Classification & Language Requirements
Are you placing products on the European Market under your name and you are concerned with classification and labeling requirements of your product? Then this group is for you! Learn more about the EU classification and mandatory language requirements!
• IVD 98/79/EC
You need a way out of the regulatory maze imposed by the IVDD directive? Then this group is for you! Join this group to receive a full-fledged picture of conformity with the IVD 98/79/EC (In-Vitro Diagnostic Medical Device).
• Free Sales Certificates
Are you a non- European manufacturer aiming at selling CE marked medical devices to international markets and you require a Free Sales Certificate by a European Authority? Join this group to be one step closer to the solution!
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