Shanghai Easy-Flow Medical Tech Co., Ltd. ("Easy-Flow™") has recently gained the ISO 13485:2016 certification for Medical Device and Quality Management System. The scope of the certification covers the design and development, production and distribution of active and non-active medical devices.

ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes is an internationally recognized, stand-alone QMS standard of safety and efficacy for medical device industry, which specifies requirements for a quality management system used by an organization demonstrating its ability to provide medical devices and related services that consistently meet strict regulatory and customer requirements. 

The credential demonstrates that Easy-Flow™'s quality management system conforms to the world-class healthcare standard for the design, manufacturing and distribution of medical devices, which also represents a new stage in Easy-Flow™'s journey of delivering safe and reliable products to benefit more patients with excellent quality control.