International Standard

Our Implant products are manufactured under a certified ISO 13485:2003 quality management system meeting stringent Canadian CMDCAS standards for medical devices. BIT Inc., was FDA Compliant since 1997 and sell products in the United States.




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USA FDA C Quality System Regulations

FDA C Quality System Regulations

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Canada ISO13845:2003 CAMCAS

Canada ISO13845:2003 CAMCAS

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Mexico Department of Health

Mexico Department of Health

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Russia Federation Department of Health

Russia Federation Department of Health

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China SFDA

China SFDA

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