Company certifications

Tecnoline has 2 cleanrooms class ISO 8, for a total area of 450 mq. Since 2005 the company has been certified UNI EN ISO 13485:2016. The regulation ISO 13485 defines the requirements for a system of quality management for manufacturers and distributors of medical devices, with reference to the law 93/42/EEC, as modified by the law 2007/47/EC. Through the development of a system of quality management according to ISO 13485, the manufacturers of medical devices can guarantee that their products are planned, manufactured and commercialized according to the standards established by the law itself, in order to satisfy the specific requirements of the market and of the referring laws. The ISO 13485 is a regulation with similarities with the concepts defined by the regulation ISO 9001, increasing the specific value for the medical sector, because it requires particular attention on the requirements important for the security of the medical devices put on the market.