Medical device ISO13485, CE certificate?

"CE" mark is a kind of safety certification mark, is regarded as the manufacturer to open and enter the European market passport. CE represents the European unity (CONFORMITE EUROPEENNE). All the products affixed with the "CE" mark can be sold in the EU member states, without having to meet the requirements of each member state, thus realizing the free flow of goods within the EU member states.

ISO13485 Chinese called "medical device quality management system" Because medical devices are special products to save lives, prevent diseases and treat illnesses, only according to the general requirements of the ISO9000 standard to regulate is not enough, for this reason the ISO organization promulgated the ISO13485: 1996 version of the standard (YY / T0287 and YY / T0287 and YY / T0287 and YY / T0287 and YY / T0287 and YY / T0287 and YY / T0287). T0287 and YY/T0288), the quality management system of medical device manufacturers put forward special requirements for the quality of medical devices to achieve safe and effective play a good role in promoting.