Certificates Home > About us > Certificates >

SWOT adheres to the highest standards for the manufacture of medical devices.

Our quality management system according to the ISO 13485:2003 is certified by TUV and pass the FDA inspection based on QSR 820.

Our medical devises meet the requirement of EU Medical Devices Directive MDD 93/42/EC and applicable standards.

ISO 13485:2003 - Design, Manufacture and Inspection of Medical Laser and Radio Frequency Devices. Certification by TUV against


© 2015 - Copyright Shanghai Wonderful Opto-Electrics Tech.Co.,LTD - All Rights Reserved Designed by GreatMo 沪ICP备05017075号-1