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Quality

Within the Hub details of the certification of each product is provided including:
  • ISO: ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
  • CE: CE Marking indicates that your medical device complies with the applicable EU regulations and enables the sale of products in 32 European countries.
  • FDA: FDA approval indicates that the medical device complies with the applicable USA regulations and enables the sale of products in America.