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Regulatory

Quality System

Our system is embracing ISO13485:2016; 21CFR 820 & 807for FDA; MDD 93/42/EEC for Europe; MDSAP for US, Canada, Japan, Australia and Brazil; CFDA for China…etc.

Registration Support in any Markets

Regulatory compliance is paramount to the commercialization of a product. With over 30years experience in the medical device industry, we have well adaptation to the complex regulatory requirements in markets all over the world.

Product Registration

We are experienced in creating technical files and documentations to support the product registration in different countries with different systems; e.g. 510K for FDA; CE for Europe; CFDA for China; and many others for rest of the world markets.

Other Compliances for International Standards

ISO 14971 for Risk Management; IEC 60601 for product safety; ISO 10993 for biocompatibility; ISO 11135 & 11137 for ETO and Gamma Sterilization ; ISTA & ASTM for packaging….etc.

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