Lianuoy successfully passed the ISO13485 audit

NQA conducted a strict and comprehensive audit of our company in accordance with the ISO13485 certification standard. With the joint efforts of everyone, the company successfully passed the audit. and got a certificate On February 14, 2022.

The full name of ISO13485 is "Medical device-Quality management system-requirements for regulatory", which is a completely independent standard specially used in the medical device industry. It is based on the ISO9001 "Quality Management System Requirements" standard.

Due to medical devices are special products for saving lives, preventing and curing diseases, it is not enough to regulate only according to the general requirements of the ISO9000 standard.The quality management system of device manufacturers has put forward special requirements, which has played a good role in promoting the quality of medical devices to be safe and effective.

Therefore, the ISO13485 certification standard is also based on medical device regulations, emphasizing the importance of implementing medical device regulations, proposing relevant medical device regulatory requirements, and ensuring the safety and effectiveness of medical devices by meeting medical device requirements. The implementation version until April 2022 is ISO13485:2016 "Requirements for Medical Device Quality Management Systems for Regulations".

Auditors working in ISO13485 Highly praised of our quality management system. And put forward some constructive suggestions for the problems found in the audit. All departments of our company will implement rectification based on the improvement requirements and process requirements of internal audit.

We will try our best to support good service for all of our customers.