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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)

  • US FDA Facility Registration

  • EU ISO13485 Certificate

  • Canada ISO13485 Certificate

  • Korea FDA GMP Certificate

  • Brazil ANVISA Certificate

  • Nigeria Registration