Stratasys Ltd. has announced that its Stratasys Direct manufacturing facility in Tucson, Arizona, has received ISO 13485 certification. This internationally recognized standard specifies quality management requirements for the manufacture of medical devices. Stratasys 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 quality of its 3D printed components. This helps medical device manufacturers to more easily meet regulatory requirements and scale their production. At the same time, development times can be shortened and manufacturing costs reduced. 3D printing enables the production of complex structures and patient-specific components that are difficult to realize using conventional methods.
“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.”
ISO 13485 certification is an important step in consolidating additive manufacturing as an established part of medical technology. Manufacturers benefit from consistent quality and can more easily adapt to regulatory requirements. Stratasys Direct will showcase its developments at the MD&M West show from 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.
