 |
ISO 9001:
International Standard Organization ISO 9001 Certified Quality System
(We canceled it on Oct. 2017)
|
 |
Quality systems:
Medical devices Quality system. ISO13485:2016 |
 |
Quality systems:
Medical devices for Canada, USA and Australia |
 |
GMP/ROC:
Taiwan Ministry of Health and Welfare, Good Manufacture Practice |
 |
CE MARK: European Committee MARK
EMC: Electro Magnetic Compatibility (radio frequency interference)
MDD: Medical device directives
PS. MDD CE expired on Oct. 2022.
|
 |
USA/FDA 510K:
USA/FDA Medical Device Premarket Notification |
 |
cTUVus:
The safety certificate of medical device for Canada and USA.
(We canceled it from initial of 2018.)
|
