First of all, a brief introduction to ISO 13485 certification, ISO13485 Chinese called “medical device quality management system for regulatory requirements” As medical devices are special products to save lives and prevent diseases, 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/T0288) for medical device manufacturers to put forward special requirements for the quality of safety and effectiveness to play a role in the quality of medical devices. ISO13485: 1996 version of the standard (YY/T0287 and YY/T0288), which puts forward special requirements for the quality management system of medical device manufacturers, and plays a good role in promoting the quality of medical devices to achieve safety and effectiveness.

The executive version until November 2017 is ISO13485:2016 “Requirements for the use of quality management systems for medical devices for regulatory purposes”. The name and content have been changed from the previous version.

Silikon Tüp Avantajları

Silikon Tüp Avantajları

Meanwhile, the certification of ISO 13485 has the following important significance:

1, improve and improve the management level of the enterprise, avoid legal risks, and increase the visibility of the enterprise;
2、Improve and ensure the quality level of products, so that enterprises to obtain greater economic benefits;
3, is conducive to the elimination of trade barriers, access to the international market pass;
4, is conducive to enhancing the competitiveness of products, increase the market share of products.
5、Through effective risk management, effectively reduce the risk of product quality accidents or adverse events.
6、Improve the sense of responsibility, enthusiasm and dedication of employees.

As a silicone tube manufacturers, through the ISO 13485 certification is not only a recognition of the strength of the enterprise, but also a kind of affirmation and guarantee of product quality, can give the majority of medical device manufacturers more assured choice and confidence in the guarantee.

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