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The applicable object of ISO13485:2016

Medical product manufacturers and service providers that comply with international, European and national laws and regulations, and enterprises that wish to implement a documented management system according to this standard. Companies that develop, manufacture and sell medical devices and want to demonstrate their ability to compete and perform in international, European and national markets. Suppliers and other service providers within the value-added chain must ensure that their products are consistent with customer requirements.

Enterprise earnings after certification

ISO13485 mandatory certification, increasingly by Europe and the United States and The Attention of Chinese government agencies, is conducive to the elimination of technical barriers in international trade, is to obtain access to the international market pass;

Increase the visibility of the enterprise;

Can improve and guarantee the quality level of products, so that enterprises get greater economic benefits;

Enhance the competitiveness of products;

It can improve and standardize the internal working process and system of the enterprise.

The applicable object of ISO13485:2016

Enterprise earnings after certification

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