Biotecan obtained the accreditation of ISO 13485:2016 Quality Management System23 April 2020
On April 22th，2020，Shanghai Biotecan Pharmaceuticals Co., Ltd passed the authorization and the audit of the ISO13485:2016 Quality Management System, and obtained the certificate of accreditation for medical instruments.
ISO13485 is the general standard of the international medical instruments industry and the important reference of quality management system certification for the domestic medical instruments industry. The accreditation of ISO 13485:2016 Quality Management System is a strong proof that Biotecan’s R&D, manufacture and marketing of in vitro diagnostic reagents and instruments have satisfied the requirements of the international quality standards and regulations.
Biotecan always put the products quality in the first place, and will adopt stricter standards to provide the customers with in vitro diagnostic reagents and instruments that meet the international standards and world-class medical testing services.