Eurosets’ products are present in over 60 countries; the Regulatory Affairs office develops the technical dossiers for the CE marking, prepares the dossier for the 510(k) approval for the United States and handles the registrations of medical devices with the various Ministries of Health and competent authorities of non-EU countries.
The Eurosets Quality Assurance Department performs tests from the raw materials up to the finished product and offers the customer post-marketing assistance and guarantees product quality in accordance with European and international regulatory requirements. It also implements the procedures required to maintain a certified Quality System in accordance with the medical device standards such as ISO13485 and MDSA for Canada, USA, Brazil, Australia and Japan.
