Advanced Materials gets ISO certification

Advanced Materials (AMI; Dallas) said that it has achieved ISO 13485 certification, which signifies the positive assessment of the company's medical device quality system.

As a supplement to the ISO 9001, the ISO 13485 is an international standard that represents the requirements of a comprehensive management system for the design and manufacturing of medical products. Some of the additional requirements relate to design controls, process controls, special processes, traceability, record retention, and regulatory actions.

Compliance with the ISO 13485 is often seen as a company's first initiative to meet European regulatory requirements. The result of a positive assessment of a medical device quality system is the authorization of the CE-Identification and permission to sell these products in the European Union.

AMI makes medical, consumer and industrial products for medical OEMs.