Quality System
US FDA registered
Passed US FDA inspections in the past 3 consecutive times (2008 & 2016 with “ZeroDefect”)
Comply with CGMP/QSR requirements
EU ISO 13485:2016 certified
Comply with IVDD 98/79/EC
Comply with MDD 93/42/EEC
Passed annual and unannounced TÜ V SÜ D audits from 1999
Canada ISO 13485:2003 certified、Comply with CFDA MDD/IVDD
Passed a variety of authoritative on-site audits from different nations
Germany TÜ V SÜ D, France LNE, Brazil ANVISA, Nigeria FDA, GCC SGH, Iran MOH, Korea FDA,Ukraine MCC, etc.
Passed the third party Supplier Qualification Audits from USA, Canada, France, Mexico,Israel, etc. (more than 10 times in total)
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US FDA Facility Registration
EU ISO13485 Certificate
Canada ISO13485 Certificate
Korea FDA GMP Certificate
Brazil ANVISA Certificate
Nigeria Registration
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质量认证