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- USA/FDA 510K: USA/FDA Medical Device Premarket Notification
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|
- USA/FDA: USA Food and Drug Administration
- GMP: FDA Good Manufacturing Practice
|
|
- UL/CSA: American Underwriter Laboratories Inc. and Canadian Standards Association
|
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- NS-EN46001: UK medical device and material QA standard
- MDD: Medical device directives
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- CE MARK: European Committee MARK
- EMC: Electro Magnetic Compatibility (radio frequency interference)
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TUV/GS |
- TUV/GERMANY: Technischer
- Uberwachungs-Verein
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| |
- GMP/ROC: Taiwan Health Department Good Manufacture Practice
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| |
- China/ FDA Medical Device Premarket Notification
|
