A GLOBAL QUALITY SYSTEM

Regularly and successfully inspected by different health authorities, including the Italian AIFA, the American and Korean FDA (Food and Drug Administration), the Brazilian ANVISA, and the notified body G-MED.

Complies with the strictest national and international regulation systems and the highest safety standards, such as EU and US cGMP (including 21 CFR Part 211, 21 CFR Part 820, a pre-requisite to manufacture and export medical devices for the US market), Quality Assurance ISO 9001:2015 and ISO 13485:2016.