How to obtain medical device ce certification

Pick up the certificate network that medical device products to successfully pass the CE certification, need to do a good job in three areas.

One, the collection and certification of products related to the European Union technical regulations and the European Union (EN) standards, through digestion, absorption, into the enterprise product standards.

The second, the enterprise in strict accordance with the above product standards to organize the production, that is, the requirements of the above technical regulations and EN standards, the implementation of the enterprise product design and development and manufacturing of the whole process.

Third, the enterprise must build and maintain the quality system according to ISO9000+ISO13485 standards, and obtain ISO9000+ISO13485 certification.