ATEK Plastics Receives ISO 13485 Certification

ATEK Plastics, a full-service precision injection molding solutions provider, recently went through a certification audit the week of April 26 -30 and is now certified to the medical standards of ISO 13485:2003.  Receiving this certification places the Company in a very small group of U.S. manufacturers qualified as decoupled molding fabricators.

The ISO Certification validates ATEK Plastics has met and will continue to meet regulatory, customer and risk management requirements while maintaining effective processes such as safe design, manufacture and distribution of medical devices. This certification aligns their management system to the requirements of the FDA’s Quality System Regulation requirements and many other regulatory requirements found throughout the world. ATEK Plastics currently serves medical device manufacturers in creating low cost components in a clean-quality driven environment and with this certification ATEK should see continued growth and opportunity.