Number: TW16/00808
Issue Date: 2018.10.08
Expiry Date: 2021.10.08
Scope/Range: Design, manufacture of non-sterile plastic components for medical use, motor controller for power medical assistive devece.
On October 2018, only two years after been certified ISO 13485-2003, Solteam Medical’s factory in Taoyuan district (Taiwan) has been certified ISO 13485-2016. Solteam Medical quality management demonstrated its ability to provide medical devices and related services that consistently meet our customer and applicable regulatory requirements.