Certified quality for medical technology products

Approval for the American market

Product safety with ISO 13485

The ISO 13485 key claim continues herein, as this certification focuses on the product safety of medical technology products. A company, having been certified according to ISO 13485 by an external certification authority, has submitted evidence to show that it ensures the product requirements through the effectiveness of the introduced processes. This is mandatory for the production and distribution of medical technology products in the European trading area. The approval for the American market is scheduled for 2016. You have questions around gKteso’s ISO 9001 or ISO 13485 certifications? Then give us a call or write us.