Basic introduction

ISO 13485 certification standard is a completely independent standard for medical device industry, which is based on ISO 9001 quality management system requirements. ISO 13485 certification standard takes medical device regulations as the main line, emphasizes the importance of implementing medical device regulations, puts forward relevant requirements of medical device regulations, and ensures the safety and effectiveness of medical devices by meeting the requirements of medical device regulations. ISO 13485 certification is a major breakthrough in the coordination between governments of various countries in recent years. It embodies the principle that the construction of quality management system of medical device manufacturers must focus on the essence of safety and effectiveness. Many requirements of this principle are embodied in government laws and regulations, and are included in government laws and regulations. ISO 13485 certification standard aims to promote the harmonization of medical device regulations all over the world.

Standard features

Medical equipment is an important basis for the construction of medical and health system. It has a high degree of strategic, driving and growth. Its strategic position has been widely valued by all countries in the world, and has become an important symbol of a country's scientific and technological progress and national economic modernization level. As a special product of saving the dying, preventing and treating diseases, the quality of medical devices is directly related to the health and safety of human body, and its safety and effectiveness also have higher and higher requirements. Therefore, according to the safety of medical devices and the potential harm to human body, all countries will carry out classified control and management of medical devices, and carry out strict quality certification system.

ISO 13485 certification standard is the basic principle of medical device production and quality management, which is applicable to the key processes affecting the quality of finished products in the whole process of medical device production. It can strengthen the management of medical devices, strengthen the quality control of enterprises, and ensure the personal safety of patients. It can provide users with stable quality products. It can enhance and improve the management level of enterprises, increase the visibility of enterprises. It can improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits. It is conducive to eliminating trade barriers and obtain the pass to enter the international market. It is beneficial to enhance the competitiveness of products and increase the market share of products.

The release of ISO 13485 certification standard provides an important premise and opportunity for promoting the quality management level of medical device production in China. Drawing on the experience of the FDA in the United States, and following the practices of some countries in America and Europe, we should promote the quality management of medical devices.

The implementation of ISO 13485 is conducive to the management level and product quality of medical device manufacturers in China to a new level, to ensuring the safety and effectiveness of medical devices, to deepen the supervision and management of medical devices, to the development of medical device quality certification, and to the healthy and rapid development of China's medical device industry.

The implementation of ISO 13485 certification standard has effectively improved the overall level of China's medical device industry.

Significance of implementation

1. Improve the level of enterprise's management level and legal risk avoidance and enhance the enterprises reputation;

2. Improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits;

3. It is conducive to eliminating trade barriers and obtaining the pass to march into the international market;

4. It is beneficial to enhance the competitiveness of products and 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 staff's sense of responsibility, enthusiasm and dedication.