Quality is the cornerstone of medical development and manufacturing. Our quality system is ISO certified and we are proud to present the certificate below.

About ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

This standard is adopted by CEN as EN ISO 13485:2003/AC:2007 and harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.