In July 2023, Changzhou Boyi Biotech Co., Ltd. successfully passed the ISO13485:2016/GB/T42061-2022 medical device quality management system certification and obtained the certificate after strict review by the Beijing Guoyixi Huaguang Certification Review Expert Group.

ISO13485 is the most authoritative international quality system standard in the medical device industry. Its full name is "Requirements for Medical Device Quality Management System for Regulations". It is an independent international standard for the medical device industry formulated by the International Organization for Standardization (ISO).

The normative reference document of ISO 13485 is ISO 9001, which puts forward more stringent requirements on the basis of the latter; ISO13485 is more professional and focuses on organizations in related industries such as medical device design and development, production and storage, logistics packaging, after-sales service, and final decommissioning and disposal.

The passing of this medical device quality management system certification is an affirmation of the existing management system and product quality of Changzhou Boyi Biotechnology Co., Ltd. We believe that the establishment and implementation of the quality management system will help the company continuously improve its quality management level and ensure product quality.

In the future, Changzhou Boyi Biotechnology Co., Ltd. will take this certification as an opportunity, strictly follow the quality management system standards, continue to use refined management as the basic guarantee, continuously improve internal quality control, continuously improve service levels, and provide customers with better quality products and technical services!