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