Athena GTX receives ISO Certification

Lyn Darrah
February 18, 2019.

Safety and quality are priorities for Athena GTX and the products we design and manufacture. We are pleased to announce that our facility has been certified to the ISO 13485 -2016 Standard (Medical devices – Quality Management Systems – Requirements for regulatory purposes). This is an internationally agreed standard that defines the requirements for a quality management system specific to the medical device industry:

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

For more information: https://www.iso.org/iso-13485-medical-devices.html


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