According to MDD’s guidelines, our company’s products are classified into Ⅱb and Ⅲ categories. By collecting EU technical regulations and EU (EN) standards related to certified products, we digest, absorb, and incorporate them into our company’s product standards, and strictly implement them. In the whole process of product design, development, and manufacturing, the quality system is established and maintained in accordance with ISO9000+ISO13485 standards, and it has obtained ISO9000+ISO13485 certification.
In order to successfully obtain the CE certificate, the company strictly follows the EU classification standards and relevant EN standards to test the products or entrust a competent laboratory to pass the test, and compile the technical file files of the products. ISO9000+ISO13485 quality system certification and CE certification can be carried out at the same time, but the CE certificate must be issued after the ISO9000+ISO13485 quality system certification is passed.