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
