Recently, Haiyan Kangyuan Medical Instrument Co., Ltd. successfully passed ISO13485:2016 medical device quality management system certification. The entire review takes three days, related to quality management system, process identification and analysis, management responsibilities, management review, quality objectives, data analysis, human resources, infrastructure, customer-related processes, design and development, procurement, production and service provision and warehouse, risk management, process verification, sterilization verification, traceability, identification status, product protection, monitoring and measurement equipment control, customer satisfaction Feedback (including complaint handling), warning system, internal audit, nonconforming product control, corrective and preventive measures, technical document review, etc.

This audit, verified by the audit team on site, confirmed that all processes of Kangyuan Medical research and development, production and sales are carried out in accordance with the provisions of the quality management system documents, and it is recommended to issue a certificate.

As an internationally recognized quality management system standard for the medical device industry, the new standard ISO13485:2016 (medical device quality management system for regulatory requirements) has been officially released on March 1, 2016. The 2016 version of the new ISO13485 standard adds a large number of medical device industry best practices, compatible with the requirements of some national medical device regulations, is a quality management system and regulatory registration and supervision more closely combined standards.

Kangyuan Medical passed the certification for the third time, which not only reflects the comprehensive recognition of Kangyuan products by international standards organizations, but also marks the further standardization, standardization and internationalization of Kangyuan medical quality management system.

At present, Kangyuan Medical is also carrying out the US FDA, EU MDR certification application and other work. We hope that with the support of more and more global “pass”, Kangyuan will cover all kinds of silicone catheters, temperature catheters, laryngeal mask airway catheter, endotracheal tube, suction catheter, stomach tube, various masks and other medical consumables products to the world, serving more patients around the world, and helping medical consumables products to be comprehensively upgraded!