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.