The Stratasys Direct manufacturing facility in Tuscon, Arizona, was awarded ISO 13485 certification, which is an internationally recognized standard for quality management systems in medical device production
Stratasys plans to extend this certification to its other Stratasys Direct manufacturing plants in Texas and Minnesota.
By obtaining ISO 13485 certification, Stratasys Direct is officially acknowledged for the safety, accuracy, and dependability of its 3D-printed parts. This certification tackles essential regulatory demands, eliminating obstacles to adoption and allowing medical device producers to increase production consistently while promoting innovation, lowering expenses, and enhancing patient results.
Stratasys Direct 3D produces various components for the medical sector, creating intricate shapes and personalized components that conventional techniques cannot accomplish.
“ISO 13485 certification is a game-changer for medical manufacturing,” said Gurvinder Kahlon, General Manager and Vice President, Stratasys Direct. “This achievement reflects our commitment to delivering solutions that not only meet rigorous regulatory standards but also empower the medical industry to innovate faster and deliver better patient care.”
Stratasys Direct has been providing custom 3D-printed models and components to the medical industry for many years. The ISO 13485 certification expands on that service by offering a clear path to regulatory compliance, maintaining consistent quality, and increasing market access for advanced manufacturing solutions.
SOURCE:- https://www.tctmagazine.com/additive-manufacturing-3d-printing-news/latest-additive-manufacturing-3d-printing-news/stratasys-direct-manufacturing-facility-arizona-iso-13485/
