We offer certified quality AST GmbH received certification according to DIN EN ISO 13485:2003 and EC guideline 93/42/EWG, appendix II
After the systematic and independent inspection by the LGA InterCert the AST GmbH received an official certificate for its comprehensive quality management system for the development of medical devices for the treatment of urinary stones.
This system covers all business processes, in particular product planning, production and selling of Lithotripsy Devices. With the certificate according to DIN EN ISO 13485:2003 the AST GmbH fulfils the international standards for a manufacturer of medical devices.
The Certification is the guaranty for our partners and customers that the AST GmbH develops and manufactures its Lithotripsy Devices by the world-wide highest quality standards. The establishment of a QMS according to DIN EN ISO 13485:2003 is an important milestone for the AST GmbH and everyone of their partners.