In strict accordance with ISO13485：2016、 ISO9001：2015"Quality Management System Requirements", we have established a complete quality management system and have established physics laboratories, chemical analysis rooms, precision instrument rooms, and sample keeping rooms. The functional rooms are complete with more than 30 sets of testing equipment such as acidity meter, tensile testing machine, anemometer, dust particle counter, aging test box, total organic carbon analyzer, collecting bacteria, and mold incubator. At the same time, it has a team of highly skilled inspection personnel.
1）Raw material control
The main raw material selection brand manufacturers. At the same time, we strictly in accordance with internal control standards for each batch of raw materials into the factory inspection.
2）Finished product control
TEAMLONG medical grade polymers meet the following requirements:
① Chinese biocompatibility standard GB15593.
② International Biocompatibility Standard ISO10093. (Equ. USP CLASS VI)
③ EU controlled substances standards REACH.
④ EU electronic control requirements RoHS.
⑤ EU Plasticizer Control Standard 2005/84/EC