Stratasys has announced that its Stratasys Direct manufacturing facility in Tucson, Arizona, has received ISO 13485 certification. This internationally recognized standard ensures that quality management systems in the manufacturing of medical devices meet the highest standards. The company plans to extend this certification to its other manufacturing facilities in Texas and Minnesota.
The certification officially recognizes Stratasys Direct for the safety, precision and reliability of its 3D printed components in the medical field. This recognition facilitates regulatory approval, supports production scaling and enables manufacturers to develop innovative medical devices faster and more cost-effectively. Particularly complex geometries and patient-specific components can be realized with additive manufacturing, which would be difficult or impossible to implement with conventional processes.
“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 supporting the medical industry for years with customized models and components. The ISO 13485 certification helps to further establish 3D printing as a key technology in the medical field. The company will showcase its manufacturing capabilities and new opportunities at MD&M West, February 4-6, 2025 in Anaheim, California.
Subscribe to our Newsletter
3DPresso is a weekly newsletter that links to the most exciting global stories from the 3D printing and additive manufacturing industry.
