Stratasys has announced that its Stratasys Direct Manufacturing facility in Tucson, Arizona, has achieved ISO 13485 certification, a globally recognised standard for quality management systems in medical device manufacturing.
This milestone underscores Stratasys’ commitment to advancing 3D printing in the medical industry by ensuring safety, precision, and reliability in the production of critical components. The company also plans to extend this certification to its other Stratasys Direct manufacturing facilities in Texas and Minnesota to further support the growing demand for regulated, high-quality medical manufacturing solutions.
By achieving ISO 13485 certification, Stratasys Direct is now formally recognised for meeting stringent regulatory requirements, removing barriers to adoption for medical device manufacturers. This certification provides a clear pathway to regulatory compliance, allowing companies to confidently scale production while accelerating innovation, reducing costs, and ultimately improving patient outcomes.
Stratasys Direct has long been a trusted partner to the medical sector, using 3D printing to produce highly complex geometries and patient-specific components that are difficult – or impossible – to achieve with traditional manufacturing methods. From surgical planning models to custom implants and device components, Stratasys’ advanced additive manufacturing capabilities enable greater customisation, shorter development cycles, and enhanced performance for medical applications.
“ISO 13485 certification is a game-changer for medical manufacturing,” said Gurvinder Kahlon, General Manager and Vice President, Stratasys Direct. “This achievement reflects our dedication to delivering solutions that meet the highest regulatory standards, empowering the medical industry to innovate faster and improve patient care.”
By adopting 3D printing, medical manufacturers can reduce development times, produce highly customised components, and bring new innovations to market faster than ever before. The certification strengthens Stratasys Direct’s position as a key enabler of medical manufacturing transformation, offering a proven, scalable, and compliant solution for next-generation medical devices.
Stratasys Direct will showcase its expertise and 3D printing capabilities at MD&M West, taking place 4-6th February 2025, in Anaheim, California.
