The international standard ISO 13485 specifies requirements for a quality management system whereby an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
An internal assessment undertaken by X-FAB confirmed that the installed quality management system covers all requirements of the ISO 13485 standard except the product and application related assurance activities and requirements. As X-FAB operates as a foundry provider and sells processed silicon wafers to its customers, the responsibility of the final product remains on the customer side. The internal assessment came to the conclusion that we can declare compliance with ISO 13485, and we are fully committed to support our customers in fulfilling the medical quality standard.
Please find the Declaration of Compliance to ISO 13485 here.
Should you have any questions with regards to this compliance declaration, please contact us by sending an email to info(at)xfab.com.