Expanding opportunities for medical device manufacturers to leverage 3D printing

Stratasys has announced that its Stratasys Direct manufacturing facility in Tuscon, Arizona has achieved ISO 13485 certification, a globally recognised standard for quality management systems in medical device manufacturing. The company plans to extend this certification to its other Stratasys Direct manufacturing facilities in Texas and Minnesota.

By achieving ISO 13485 certification, Stratasys Direct is formally recognised for its safety, precision, and reliability of its 3D printed components. This certification addresses critical regulatory requirements, removing barriers to adoption and enabling medical device manufacturers to scale production reliably while accelerating innovation, reducing costs, and improving patient outcomes.

Stratasys Direct 3D prints multiple components for the medical industry making complex geometries and patient-specific components that traditional methods cannot achieve.

‘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.’

The company has been a trusted partner to the medical field for years, delivering custom 3D printed models and components. The ISO 13485 certification builds on that legacy, positioning 3D printing as an essential tool for the medical device industry. By adopting 3D printing, medical manufacturers can reduce development times, create highly customised components, and innovate faster than with traditional manufacturing methods. This ISO 13485 certification provides a clear pathway to regulatory compliance, ensuring consistent quality and expanding market access for these advanced manufacturing solutions.