Stratasys Grows Market for Medical Device Manufacturers

Stratasys Ltd. announced that its Stratasys Direct manufacturing facility in Tuscon, AZ, has achieved ISO 13485 certification, a globally recognized standard for quality management systems in medical device manufacturing. Stratasys 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 recognized for its safety, precision, and reliability of its 3D-printed components, the company reports. This certification addresses regulatory requirements, enabling medical device manufacturers to scale production while improving patient outcomes, Stratasys notes.

“ISO 13485 certification is a game-changer for medical manufacturing,” says 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 a partner to the medical field for years, delivering custom 3D-printed models and components. Stratasys Direct says its ISO 13485 certification provides a pathway to regulatory compliance, ensuring consistent quality and expanding market access for these advanced manufacturing solutions.

Sources: Press materials received from the company and additional information gleaned from the company’s website.

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