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Quality

Our factory operates in accordance with the following regulations and standards:

  • The European Medical Device Directive 93/42/EEC 
  • The US Medical Device Quality Systems Regulation (QSR)
  • The Quality Management Standards ISO 9001 and ISO 13485

As a CE certified & FDA registered company we have established a complete rigorous quality management based on these standards & regulatory requirements to ensure the quality stability and security of our products.

Quality System Certificate and CE certificate

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