ISO 13485, also known as 'Medical Device Quality Management System' in Chinese, is a special product for saving lives, helping injuries, and preventing and treating diseases. It is not enough to standardize medical devices solely according to the general requirements of the ISO9000 standard. Therefore, the ISO organization has issued the ISO 13485-1996 version standards (YY/T0287 and YY/T0288), which put forward special requirements for the quality management system of medical device manufacturers, and has played a good role in promoting the safety and effectiveness of medical device quality.
ISO13485 is a quality management system based on the ISO9001 process method used in the medical device industry for regulatory requirements. It includes special requirements for the manufacturing, installation, service, and recall of medical devices to facilitate:
-Improving the quality management system
-Use risk management methods for control during the product implementation process
-Process validation
-Meet the requirements of laws and regulations
-Effective control of product risks and recall management
The Benefits of ISO13485 Certification
-Helps to eliminate technical barriers in international trade and is a passport to enter the international market
-Improve the management level of the organization
-Enhance business reputation
-Improve the level of ensuring product quality
-Beneficial to enhancing the competitiveness of enterprises
-Improve internal management of the organization